Oral and Maxillofacial Surgery Review a Study Guide
BMC Anesthesiol. 2020; 20: 127.
Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular complimentary flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial
Yun Liu
aneDepartment of Critical Care Medicine, Peking Academy 3rd Infirmary, Beijing, 100191 People's republic of china
Xi Zhu
1Department of Critical Care Medicine, Peking Academy Third Hospital, Beijing, 100191 Prc
Dan Zhou
twoSection of Anesthesiology, Peking Academy Hospital of Stomatology, Beijing, 100081 Red china
Fang Han
2Section of Anesthesiology, Peking Academy Hospital of Stomatology, Beijing, 100081 Communist china
Xudong Yang
2Department of Anesthesiology, Peking University Hospital of Stomatology, Beijing, 100081 China
Received 2019 Oct 26; Accepted 2020 May 21.
- Supplementary Materials
-
Additional file 1. The Seven ARISCAT Chance Predictors.
GUID: 5B94CA72-C3C0-440F-8A96-4862FEBF5215
Additional file 2. Definitions of Postoperative Pulmonary Complications.
GUID: F4F3951B-2CC1-4AB6-94B0-39292D23B824
Additional file 3. Criteria of grade of PPCs according to the Clavien-Dindo classification.
GUID: AA79B28F-EA42-4E3F-B483-4DFFE47C95A8
- Data Availability Statement
-
The datasets generated and/or analyzed during the current report will be bachelor from the corresponding author on a reasonable asking.
Abstract
Groundwork
Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an α2-adrenoreceptor agonist, has been proven having lung protection effects. Nevertheless, since now, in that location has not been final conclusion nearly whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs.
Methods
This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A full of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.iv μg/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 μg/kg/h till the second twenty-four hours morning after surgery. At the same fourth dimension, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7 days later on surgery.
Results
The ii groups had similar characteristics at baseline. xviii(22.5%) of lxxx patients administered DEX, and 32(twoscore.0%) of eighty patient administered placebo experienced PPCs within the first 7 days afterward surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346–0.916; P = 0.017). In the outset 7 days afterwards surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P = 0.019), and was less decumbent to occur PPCs (Cox regression, P = 0.025, 60 minutes = 0.516). When the full dose of DEX was more than 328 μg, the patients were unlikely to accept PPCs (ROC curve, AUC = 0.614, P = 0.009).
Conclusions
For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7 days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension.
Trial registration
Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.
Keywords: Dexmedetomidine, Postoperative pulmonary complications (PPCs), Oral and maxillofacial surgery, Fibular free flap reconstruction, Tracheotomy
Background
Postoperative pulmonary complications (PPCs) are a blended of the hospital-caused respiratory events after surgery, which are one of the major causes of morbidity, mortality, and prolonged hospital stay in patients after surgery [1–three]. Oral and maxillofacial surgery is considered ane of surgical factors which nearly probable to interfere with respiratory function and strongly linked to PPCs [4], especially radical oral and maxillofacial cancer surgery with microvascular free tissue transfer, such equally fibular costless flaps. Previous studies take demonstrated that 18.viii to 44.8% [4–8] of the patients undergoing head and cervix surgery with free flap surgery would accept PPCs, while in such kind of patients with tracheostomy the incidence of PPCs could fifty-fifty be 47% [half-dozen, 9]. Therefore, it is necessary to prevent and reduce the occurrence of PPCs in patients undergoing oral and maxillofacial surgery, which is a specific surgical sub-cohort within head and neck surgery, with fibular free flap reconstruction and tracheotomy.
Dexmedetomidine(DEX) is a new highly selective α2 adrenoceptor agonist which has anxiolysis, sedation, and modest analgesia with minimal respiratory depression furnishings [10] and has been widely and safely used in oral and maxillofacial surgeries [11]. Studies have proved that DEX could attenuate perioperative stress, inflammation, and protect the immune function of surgical patients [12], and can provide clinically postoperative pulmonary relevant benefits past improving oxygenation and lung mechanics [13, fourteen], all of which may contribute to decreased postoperative complications and improved clinical outcomes. In the terminal few years, a few clinical trials have evaluated the effect of DEX on PPCs [13–19]. Yet, the results of these studies are markedly variable and appear to be underpowered. And so, since now, at that place has not been final determination nearly whether or not DEX can reduce the incidence of PPCs. As for the event of DEX on PPCs in oral and maxillofacial surgeries, none of clinical trials take ever involved.
The purpose of the present report was to investigate whether DEX can reduce the incidence of PPCs during the initial seven postoperative days in patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who are at intermediate-to-high risk for PPCs.
Methods
Trial design
We did this prospective, double-blind, randomized, placebo-controlled, unmarried-center, clinical trial in the department of anesthesiology of Peking Academy Hospital of Stomatology, a tertiary academic hospital in Beijing, China. The ideals was approved by Peking University Hospital of Stomatology Biomedical Ethics Committee (Number: PKUSSIRB-201735060) on January 26, 2018. The trial was registered with Chinese Clinical Trial Registry, www.chictr.org.cn (Number: ChiCTR1800016153) on May 15, 2018. This manuscript reporting adhered to Espoused guidelines.
Written informed consent was obtained from all participating patients or their next of kin or legal representative who must understand the recruiter's description of the trial. The main aim of the written report was to evaluate the supremacy of the intervention. Entitled patient were enlisted and arbitrarily designed to benefit i of the interventions, DEX or placebo (normal saline).
Randomization and blinding
A biostatistician from Peking University Third Hospital, who was independent of data direction and statistical analyses, generated random numbers (in a i:1 ratio) using the SAS ix.2 software (SAS Institute, Cary, NC, USA). The results of randomization were sealed in sequentially numbered envelopes. Throughout the survey period, enlisted patients were unpremeditated chosen to obtain DEX or placebo. A survey anesthesiologist, according to the arbitrarily series those not taking office in the survey applied the survey medicine.
The investigators, health-intendance squad members (including the attending anesthesiologists, surgeons, nurses and the physicians for postoperative follow-up) and patients were blind to the handling group assignment throughout the study menstruation. In case of emergency, (such as development of severe adverse events, persistent hemodynamic instability or rapid deterioration of the patient's clinical status), the attention anesthesiologist could request to unmask the allocation, and adjust or even stop study drug infusion if necessary. These non-blind situations were documented, but the terminal analyses were performed on the intention-to-treat population.
Participants
Patients were included if they (1) were scheduled for oral and maxillofacial surgery with fibular gratuitous flap reconstruction that was expected to exceed 3 h under general anesthesia, (two) were 51 years old or over, (3) took tracheotomy earlier the stop of the surgery, (4) had an intermediate to high risk of developing PPCs judged by Assess Respiratory Adventure in Surgical Patients in Catalonia (ARISCAT) score [twenty](cumulative ARISCAT risk score were 26 or greater) (Additional file i).
Patients were excluded if they met the following criteria: (ane) body mass alphabetize of 35 or higher, (two) allergic to DEX, (3) contempo sedatives-taking history, (four) sick sinus syndrome, or astringent sinus bradycardia(< l beats per min[bpm]), or second degree or greater atrioventricular block without pacemaker, (5) previous lung surgery history, or severe chest wall malformation, or acute exacerbation of chronic obstructive pulmonary disease (AECOPD), or uncontrolled asthma (Asthma control test ≤18), or pulmonary avenue stenosis, or pulmonary hypertension, (6) complex centre deformities, congestive center failure, or known preoperative left ventricular ejection fraction less than 30%, (7) serious hepatic dysfunction(Child-Pugh class C), or serious renal dysfunction(requirement of renal replacement therapy), (viii) a history of mental affliction, (ix) refused to participate in the clinical trial.
Interventions, anesthesia and perioperative management
The study drug DEX, dexmedetomidine hydrochloride injection two ml: 0.2 mg (manufactured by Yangtze River Pharmaceutical (Grouping) Co., Ltd., Jiangsu, China), was diluted with normal saline to 50 mL (the last concentration of DEX was 4 μg/mL) by a nurse, who did non participate in the residue of the study, before administration. The study drug (diluted DEX) and placebo drug(normal saline)were all provided equally articulate aqueous solution in the same fifty ml injection syringes and dispensed according to the randomization results. The two drugs were given as an initial dose of 0.1 ml/kg (0.iv μg/kg of DEX in the treatment grouping) over 10 min followed by a maintenance dose of 0.i ml/kg/h (0.4 μg/kg/h of DEX in the treatment group) from the showtime of anesthesia induction on the twenty-four hour period of surgery until 0600 h on the first day after surgery.
All patients followed the similar anesthesia and perioperative management regimen. Half an 60 minutes before the beginning of the surgery, prophylactic antibiotics (mostly cefuroxime ane.five g, the second-generation cephalosporin) were routinely administered and employ again at the fourth hour within the functioning fourth dimension when the surgery time was longer than 4 hours. Subsequently surgery, routine antibiotics with cefuroxime 1.five g twice a day and ornidazole 0.v g twice a day for 6 days were administered. The choice and the duration of antibiotics handling were decided co-ordinate to the Guiding Principles of Clinical Use of Antibiotics (2015 edition) which was published by Chinese National Health and Family unit Planning Committee in 2015.
Perioperative monitoring included continuous 5-lead electrocardiogram, pulse oxygen saturation, noninvasive claret pressure, Railroad train-of-Four ratio (TOF, T4/T1) for measuring the level of neuromuscular blockade, Bispectral Alphabetize (BIS) (Covidien, Us) value, finish-tidal carbon dioxide concentration (EtCO2), airway pressure, axillary temperature, urine output. Intra-arterial pressure was also monitored through cannulation of the arteria dorsalis pedis (on the opposite of the surgical leg) immediately subsequently anesthesia induction.
All patients were performed general anesthesia with nasotracheal intubation. Anesthesia was induced in both groups with 0.05 mg/kg midazolam, 0.3 μg/kg sufentanil, 2 mg/kg propofol, and 0.vi mg/kg rocuronium, and maintained with target-controlled infusion (TCI) of propofol (2 to vi μg/ml plasma concentration) and remifentanil (0.5 to 6 ng/ml plasma concentration), without inhalational sevoflurane and nitrous oxide. During functioning, in accordance with hemodynamic state, surgical steps and TOF ratio, additional analgesia was administered by applying boluses of sufentanil 0.1 to 0.5 μg/kg and muscle relaxation was achieved by intermittent injection of rocuronium 10 mg each time. BIS value was maintained between 40 and threescore.
Volume-controlled mechanical ventilation was established with the fraction of inspiration O2 (FiO2) from 0.4 to 0.6, the tidal volume from vi to viii ml/kg (ideal weight), the positive cease-expiratory pressure (PEEP) 5 cm H2O. The respiratory charge per unit was adapted to maintain EtCO2 between 35 and 45 mmHg.
Fluid management was performed according to routine practice with crystalloids - sodium lactate ringer's injection and/or colloids - vi% hydroxyethyl starch (HES) 130/0.iv sodium injection. Packed cherry claret cells were transfused while the hemoglobin level was lower than vii yard/dl.
Earlier the end of the surgery, all patients underwent tracheotomy afterwards spontaneous breathing recovery (TOF ratio > 0.9). After surgery, all patients were transferred to the postoperative intendance unit (PACU) and supervised until 0830 h on the first day after surgery before sent back to the full general wards.
During the postoperative menses, intravenous patient-controlled analgesia with sufentanil one.0 ~ one.5 μg/kg and tropisetron ten mg was provided for up to 48 h. All patients were given aerosol inhalation with ambroxol 60 mg and hydrocortisone 4 mg 3 times a day before discharge and mechanical vibration sputum expectoration (TC Juhnson) 3 times a day for five days. Usually on the fifth day after surgery, the tracheostomy tube was removed after the oral and maxillofacial surgeons evaluating the situation of the airway and operation expanse. Other treatments including early mobilization (routinely on the fourth postoperative day), anticoagulant therapy (routinely 5 days, with aspirin or low molecular heparin), enteral and parenteral nutrition were administered according to routine practice.
The adverse events (bradycardia and hypotension) were monitored and documented throughout the period of study drug infusion. Bradycardia was defined as heart rate less than 50 beats/min or a decrease of more than twenty% from baseline. Hypotension was divers as systolic blood pressure level less than ninety mmHg or a decrease of more than than xx% from baseline. Intervention for bradycardia included administration of medication (atropine by and large) or aligning of study drug infusion, or both. Intervention for hypotension included intravenous fluid bolus, or administration of vasoactive drugs (ephedrine, methoxamine, etc.) or adjustment of written report drug infusion. All interventions were recorded.
Outcomes
The postoperative daily follow-up menstruation was vii days. Research members who were trained earlier the written report and not involved in the clinical care of patients did the issue assessment.
Primary outcome
The master outcome was the incidence of PPCs within 7 days later surgery. PPCs was defined as any preselected complication occurred, which included respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pulmonary edema, pulmonary embolism, and acute respiratory distress syndrome. The diagnostic criteria of each individual PPCs were like with those used in the previous studies [ane–iii](Boosted file 2). We chose the Clavien-Dindo Nomenclature [21] to categorize PPCs into v major groups (Additional file 3). In our study, PPCs of course Ii or above were considered to calculate the incidence of PPCs. The diagnosis of PPCs was made past the attention medical team (anesthesiologists, Intensive Intendance Union physicians, or respiratory physicians). The physicians diagnosed PPCs according to patients' medical history, clinical physical examination, conventional monitoring value, laboratory results, image test, and then on. If a PPC occurred, the date of earliest diagnosis and the evidences according to which the diagnosis was fabricated were documented.
Secondary outcomes
The secondary outcomes were every bit follows: (1) the time to kickoff diagnosis of PPCs - indicated the time from end of surgery to outset diagnosis of PPCs inside 7 days after surgery; (2) the number of PPCs - indicated the number of diagnosed individual PPCs within 7 days afterward surgery; (iii)the dose-effect relationship between DEX and PPCs; (iv) the incidence of postoperative extrapulmonary complications - divers every bit complications other than PPCs that occur during functioning and within seven days later on surgery, and require therapeutic intervention, included delirium – assessed past the Defoliation Assessment Method for the ICU (CAM-ICU) [10], anemia - defined every bit hemoglobin less than 9 g/dL, extrapulmonary infection; (5) the unexpected need for secondary surgery (hematoma or vascular crunch exploration); (half dozen) the agin events (bradycardia, hypotension) during the period of study drug infusion; (7) length of stay in hospital after surgery; (8) xxx-day all-cause mortality.
Sample size and statistical methods
Nosotros used the splendid upshot test of two groups of independent sample rate to calculate the sample size. According to the literature data [16], the sample size was calculated according to the incidence of postoperative pulmonary complications. The incidence was iii.89% in the experimental grouping (DEX group) and 17.99% in the control group. The class I error of hypothesis test was 0.025, the form II error was 0.two, and the proportion of sample size between the examination group and the command grouping was ane:one. The sample size was calculated by Stata 10.0 software Co-ordinate to the bilateral test formula of sample size: northward = ii × (U α + U β) 2 × P (1-P) / δ two, δ was set to 0.01. The sample size of the test group was 64 and that of the control group was 64. Taking into business relationship the dropout rate of 20%, each group requires a sample size of 76.8, so we planned to enroll 160 patients (80 for each grouping) in all.
Nosotros analysed event data and safety in the intention-to-treat population. Statistical analyses were performed on SPSS version 24.0 software (SPSS, Chicago, IL, U.s.a.) and P values less than 0.05 were considered to be of statistical significance. Statistical description was provided for baseline information such every bit demographic variables, medical history, perioperative medications, and perioperative management. For master event (the incidence of PPCs with 7 days subsequently surgery), the result of the intervention was reported every bit number and per centum and estimated with relative risk and 95% confidence interval and the χ2 test for hypothesis testing. For secondary outcomes, continuous variables with normal distribution were analyzed using an unpaired t examination; continuous variables with aberrant distribution or ranked data were analyzed by Mann-Whitney U exam; categorical variables were analysed with the χ2 test, continuity correction χ2 test or Fisher exact examination. Time-to-event results were calculated with the Kaplan-Meier computer, and the differences between groups were assessed past the log-rank test. And, Cox regression was used for survival assay. For dose-effect relationship, receiver operating characteristic (ROC) bend was used for calculating the P and cutoff values.
Results
Participant menstruum and recruitment
Between September three, 2018 and July 31, 2019, a total of 624 patients who were scheduled for oral and maxillofacial surgery with complimentary flap reconstruction were screened for report participation; of these, 160 patients were enrolled into the report and randomly assigned to receive either DEX (n = 80) or placebo (n = 80). Report drug infusion was modified in nine patients considering of adverse events. Three patients were discharged from the hospital within 7 days after surgery. In that location were no lapses in the blinding. All patients were included in the final intention-to-treat analyses (Fig.one). The last follow-up of the final randomized patient was finished on Baronial 31, 2019.
Catamenia Diagram of Patients Through Trial
Baseline patient demographic and perioperative characteristics
Overall, the two groups were well matched for all the variables.
Both baseline patient demographic and preoperative characteristics share the same features. (Tabular arrayone).
Tabular array one
Baseline Patient Demographic and Preoperative Characteristics
| Characteristic | Dexmedetomidine group (due north = 80) | Placebo group (n = 80) | P value |
|---|---|---|---|
| Age, median (IQR), twelvemonth | 59 (55, 65) | 62 (56, 67) | 0.123 |
| Sex, No. (%) | |||
| Male | 51 (63.viii) | 53 (66.3) | 0.740 |
| Female | 29 (36.3) | 27 (33.8) | |
| Hight, median (IQR), cm | 168.0 (160.0, 171.5) | 166.00 (160.0, 172.0) | 0.832 |
| Weight, median (IQR), kg | 60.50(55.0, 69.5) | 62.00 (57.5, 71.0) | 0.284 |
| BMI, median (IQR) a | 22.59 (20.36, 24.16) | 22.xc (21.03, 25.10) | 0.283 |
| ARISCAT score b | |||
| Intermediate risk, No. (%) | 77 (96.3) | 79 (98.eight) | 0.311 |
| High risk, No. (%) | 3 (iii.8) | 1 (i.three) | |
| Mean (SD) | 28.36 (4.82) | 28.32 (four.81) | |
| ASA physical status classification, No. (%) c | |||
| 1 | 16 (20.0) | 17 (21.3) | 0.216 |
| 2 | 61 (76.iii) | 63(78.7) | |
| 3 | 3 (3.8) | 0 (0) | |
| NYHA heart failure class, No. (%) d | |||
| I | 47 (58.8) | 51 (63.seven) | 0.516 |
| II | 33 (41.ii) | 29 (36.2) | |
| Tobacco apply, No. (%) | 31 (38.eight) | 29 (36.ii) | 0.744 |
| Alcohol apply, No. (%) e | 25 (31.3) | 21 (26.3) | 0.485 |
| Preoperative SpO2, No. (%) | |||
| ≥ 96 | 67 (83.8) | 68 (85.0) | 0.975 |
| 91–95 | 12 (xv.0) | xi (13.8) | |
| ≤ 90 | i (1.3) | 1 (1.three) | |
| Preoperative anemia (Hb ≤ 10 g/dl), No. (%) | ix (11.3) | v (6.three) | 0.263 |
| Mean (SD), g/dl | 13.54 (2.03) | 13.72 (1.92) | |
| Comorbidity | |||
| Arterial hypertension, No. (%) | 27 (33.viii) | 24 (30.0) | 0.611 |
| Diabetes, No. (%) | 9 (11.three) | 12 (fifteen.0) | 0.483 |
| Coronary artery disease, No. (%) | 8 (ten.0) | 4 (5.0) | 0.230 |
| Arrhythmia, No. (%) | 6 (7.v) | 6 (7.five) | 1.000 |
| COPD, No. (%) | i (1.3) | 4 (5.0) | 0.173 |
| Asthma, No. (%) | 0 (0.0) | 1 (1.3) | 0.316 |
| Preoperative abnormalities on chest radiography, No. (%) | four (five.0) | 8 (10.0) | 0.230 |
| Active cancer, No. (%) | 69 (86.iii) | lxx (87.v) | 0.815 |
For intraoperative and postoperative characteristics (Tableii, Table3), the intraoperative dosages of propofol and remifentanil in the DEX group were significantly lower than the placebo group (P < 0.01), and numeric rating scale (NRS, an 11 points scale where 0 indicated the best and 10 indicated the worst) of hurting for oral and maxillofacial and fibular areas on the get-go mean solar day after surgery were both significantly lower in the DEX group than in the placebo group (P < 0.01), equally well equally the sleep time on the beginning twenty-four hours subsequently surgery in the DEX group was longer than the placebo grouping (P < 0.01). At the same time, intraoperative urine output and total infusion on the 2nd twenty-four hour period later surgery were dissimilar in the two groups, too (P < 0.05).
Table 2
Intraoperative Characteristics
| Characteristic | Dexmedetomidine grouping | Placebo grouping | P value |
|---|---|---|---|
| (n = 80) | (n = eighty) | ||
| Cervical lymph node dissection, No. (%) | |||
| No | 17 (21.2) | 15 (eighteen.eight) | 0.719 |
| Unilateral | 45 (56.three) | l (62.5) | |
| Bilateral | 18 (22.5) | 15 (18.7) | |
| Duration of surgery, median (IQR), mina | 330 (275, 382) | 310 (263, 393) | 0.386 |
| Duration of anesthesia, median (IQR), minb | 362 (302, 428) | 358 (298, 442) | 0.732 |
| Elapsing of limb ischemia time, median (IQR), minc | 59 (53, 71) | sixty (l, 68) | 0.611 |
| Vital volume, median (IQR), ml | 425 (400, 450) | 425 (400, 450) | 0.860 |
| Respiratory rate, median (IQR), breaths/ min | 12 (12, 13) | 12 (12, fourteen) | 0.905 |
| Peak pressure, median (IQR), cmH2O | |||
| Later intubation | 15 (thirteen, sixteen) | fourteen (13, 16) | 0.281 |
| The highest during the surgery | 16 (14, 18) | 16 (14, xviii) | 0.989 |
| Earlier the end of the surgery | fifteen (14, 17) | xv (14, 17) | 0.664 |
| FiO2, median (IQR) | 50 (l, fifty) | 50 (l, 50) | 0.277 |
| Intraoperative medication, median (IQR) | |||
| Sufentanil, μg | xxx (twenty, 40) | 30 (25, 45) | 0.083 |
| Propofol, mg | 1200 (one thousand, 1500) | 2500 (2000, 2700) | 0.000 |
| Remifentanil, μg | 1450 (1000, 1980) | 2625 (1700, 3000) | 0.000 |
| Dexmedetomidine, μg | 188 (168, 200) | 0 (0, 0) | 0.000 |
| Crystalloids, median (IQR), ml | 1700 (1700, 2200) | 1700 (1600, 2200) | 0.947 |
| Constructed colloids, median (IQR), ml | 500 (500, 500) | 500 (500, 500) | 0.149 |
| Estimated claret loss during surgery, median (IQR), ml | 300 (200, 400) | 300 (200, 350) | 0.508 |
| Urine output, median (IQR) | 675 (400, 900) | 500 (350, 700) | 0.016 |
| Total intraoperative infusion, median (IQR), ml | 1450 (m, 1900) | 1450 (1075, 1875) | 0.895 |
Table 3
Postoperative Characteristics
| Characteristic | Dexmedetomidine group | Placebo group | P value |
|---|---|---|---|
| (n = eighty) | (n = 80) | ||
| Length of stay in PACU, median (IQR), min | 855 (675, 970) | 923 (730, 1020) | 0.073 |
| Medication in PACU, median (IQR), min | |||
| Dexmedetomidine in PACU | 168 (160, 184) | 0 (0, 0) | 0.000 |
| Full Dexmedetomidine on performance 24-hour interval a | 360 (338, 378) | 0 (0, 0) | 0.000 |
| Sufentanil in PACU | 0 (0, 0) | 0 (0, 0) | 0.100 |
| Total sufentanil on performance day a | xxx (25, 40) | 34 (25, 46) | 0.070 |
| Time with tracheotomy tube, median (IQR), d | 5(5,6) | 5(5,6) | 0.551 |
| Total infusion, mean (SD), ml | |||
| The operation day a | 1848.65 ± 622.996 | 1888.44 ± 690.296 | 0.702 |
| The offset day later on surgery | 931.69 ± 1108.510 | 989.25 ± 1098.572 | 0.742 |
| The second day after surgery | 861.04 ± 954.420 | 868.41 ± 1162.951 | 0.717 |
| NRS for oral and maxillofacial area pain, hateful (SD) | |||
| The first day afterward surgery | 1.30 ± 1.226 | 3.20 ± 1.363 | 0.000 |
| The second day later on surgery | ane.49 ± 1.534 | 1.53 ± one.492 | 0.876 |
| The Tertiary twenty-four hours afterwards surgery | ane.39 ± 1.497 | one.44 ± 1.231 | 0.818 |
| NRS for fibular area hurting, mean (SD) | |||
| The kickoff day later on surgery | one.59 ± 1.357 | three.71 ± one.070 | 0.000 |
| The 2nd solar day after surgery | ane.49 ± 1.369 | 1.58 ± 1.367 | 0.686 |
| The third day after surgery | i.55 ± 1.457 | ane.43 ± 1.261 | 0.563 |
| Slumber time, median (IQR), h | |||
| The first twenty-four hours later on surgery | 6.0 (5.0, seven.0) | four.0 (iii.3, 5.0) | 0.000 |
| The second twenty-four hour period after surgery | five.0 (4.3, 6.0) | 5.0 (4.0, 6.0) | 0.520 |
Main outcome and secondary outcomes
On the whole, PPCs within the first seven days afterward surgery occurred in 18 (22.5%) of eighty patients given DEX, and in 32 (40.0%) of 80 patients given placebo (relative gamble [RR] 0.563, 95% conviction interval [CI] 0.346–0.916; P = 0.017) (Table4).
Tabular array four
Primary and Secondary Outcomes
| Outcome | Dexmedetomidine group | Placebo group | Relative run a risk | P value |
|---|---|---|---|---|
| (n = 80) | (n = eighty) | (95% CI) | ||
| Primary consequence, No. (%) | ||||
| Overall incidence of PPCs | xviii (22.five) | 32(forty.0) | 0.563 (0.346–0.916) | 0.017 |
| Respiratory infection | 14 (17.5) | xix (23.viii) | 0.737 (0.398–1.356) | 0.329 |
| Respiratory failure | 3 (3.8) | vii (eight.eight) | 0.429 (0.115–1.599) | 0.191 |
| Pleural effusion | 0 (0) | 2 (2.v) | – | 0.155 |
| Atelectasis | ane (1.iii) | 5 (half dozen.three) | 0.200 (0.024–1.674) | 0.096 |
| Pneumothorax | 0 (0) | 0 (0) | – | – |
| Bronchospasm | 0 (0) | one (1.three) | – | 0.316 |
| Aspiration pneumonitis | 0 (0) | 0 (0) | – | – |
| Pulmonary edema | i (1.iii) | 2 (2.v) | 0.500(0.046–5.404) | 0.560 |
| Pulmonary embolism | 1 (1.three) | 1 (ane.3) | 1.000 (0.064–15.712) | 1.000 |
| Acute respiratory distress syndrome | 1 (1.3) | 0 (0) | – | 0.316 |
| Secondary outcome, No. (%) | ||||
| The time to offset diagnosis of PPCs a | 4 (ii, five) | 3 (2, 5) | – | 0.928 |
| The number of PPCs b | ||||
| 0.00 | 62 (77.five) | 48 (60.0) | – | – |
| one.00 | 15 (18.8) | 27 (33.8) | 0.541 (0.314–0.933) | 0.023 |
| 2.00 | 3 (three.viii) | 5 (6.iii) | 0.489 (0.123–1.954) | 0.300 |
| postoperative extrapulmonary complications c | ||||
| Delirium | 1 (i.3) | iv (five.0) | 0.250 (0.029–ii.188) | 0.173 |
| Anemia d | 3 (3.8) | ii (2.5) | i.500 (0.258–8.737) | 0.650 |
| Extrapulmonary infection | ii (2.five) | 4 (5.0) | 0.500(0.094–2.653) | 0.405 |
| Need secondary surgery eastward | four (5.0) | 6 (vii.v) | 0.667 (0.196–2.273) | 0.514 |
| Agin events | ||||
| Bradycardia f | 2 (two.5) | two (2.5) | – | ane |
| Hypotension g | 2 (2.5) | 3 (iii.8) | 0.667 (0.114–3.883) | 0.650 |
| Length of stay in hospital afterwards surgery, median (IQR), day | 9 (8, 11) | 10 (9, 11) | – | 0.036 |
| thirty-day all-cause bloodshed | 0(0.0) | 0(0.0) | – | one |
Although without numerical departure, the most mutual PPCs was respiratory infection, accounted for 14(17.5%) patients in DEX group liken to 19(23.viii%) patient in placebo group (P = 0.329). The incidence of the other PPCs (included respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pulmonary edema, pulmonary embolism, and acute respiratory distress syndrome) was low and also without statistical divergence between the ii groups (P > 0.05).
The secondary outcomes appeared in Table iv. The incidence of one kind of PPC was less common in DEX grouping (RR 0.541, 95% CI 0.314–0.933; P = 0.023), and the length of stay in hospital afterward surgery was shorter in DEX grouping (P = 0.036). However, the time to kickoff diagnosis of PPCs, the incidence of two PPCs, the incidence of extrapulmonary complications (delirium, anemia, extrapulmonary infection), the need of secondary surgery, the incidence of agin events (bradycardia, hypotension) and the 30-day all-cause bloodshed did not significantly differ between groups.
The Kaplan-Meier curves representing PPCs in the postoperative vii days between the DEX grouping and the placebo group were shown in Fig.two. The small plus sign indicated deletion, since most of the observed objects did not have an ending at 7 days subsequently surgery. The Log rank test results were shown in Table5 (P = 0.019). Therefore, the DEX group had a lower incidence of PPCs in the outset 7 days after surgery.
The Kaplan-Meier curve representing the time to occurrence of PPCs in the postoperative seven days between the DEX group and the placebo grouping
Table 5
Log rank exam of the time to onset of PPCs between ii groups
| Groups | Mean | SE | 95% Confidence Interval | P value | |
|---|---|---|---|---|---|
| Lower Bound | Upper Bound | ||||
| Dexmedetomidine grouping | 6.212 | 0.191 | 5.837 | 6.588 | 0.019 |
| Placebo group | 5.625 | 0.219 | five.196 | 6.054 | |
| Overall | 5.919 | 0.146 | 5.633 | 6.204 | |
The Cox regression results were shown in Table6 (P = 0.025, 60 minutes = 0.516). Hence, within the first vii postoperative days, the DEX group was less prone to occur PPCs.
Table vi
Cox regression of PPCs between two groups
| Groups | B | SE | Wald | P value | HR | 95.0% CI | |
|---|---|---|---|---|---|---|---|
| Lower | Upper | ||||||
| Dexmedetomidine group | −0.662 | 0.295 | v.035 | 0.025 | 0.516 | 0.290 | 0.920 |
| Placebo grouping | reference | ||||||
The ROC curve results were shown in Fig.3 and Table7. The surface area nether the ROC curve (AUC) was 0.614, P = 0.009 < 0.05, indicating that the cutoff value made by the ROC curve was statistically significant in predicting the incidence of PPCs. The sensitivity and specificity were respectively 78.00 and 49.09% and the cutoff value was 328. Hence, when the full dose of DEX on operation day was no more than 328 μg, the patients might have PPCs postoperatively, and when DEX was more than than 328 μg, PPCs were unlikely to occur.
The ROC curve representing the human relationship betwixt total dose of DEX and the incidence of PPCs in the postoperative 7 days
Tabular array 7
The Area Under ROC curve and Youden Index
| Index | Value |
|---|---|
| Area under ROC curve | 0.614 |
| Std. Mistake | 0.0441 |
| 95% confidence interval | 0.534–0.690 |
| P value(area = 0.5) | 0.0094 |
| Youden Index | 0.2709 |
| Cutoff | ≤328 |
| Sensibility | 78.00 |
| Specificity | 49.09 |
Word
Our results suggested that DEX infusion greatly decreased the occurrence of PPCs (including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pulmonary edema, pulmonary embolism, and acute respiratory distress syndrome) during the first seven days subsequently surgery. At the same time, DEX assistants also significantly reduced the incidence of i kind of PPC and shortened the length of stay in infirmary afterwards surgery. Moreover, In the first seven days subsequently surgery, the DEX grouping had a lower incidence of PPCs and was less prone to occur PPCs. Furthermore, when the total dose of DEX was more than 328 μg, the patients were unlikely to accept PPCs.
Our finding was in accordance with the previous randomized controlled clinical studies by Meiyue Liu in 2018 [sixteen] (3.89% vs. 17.99%, P < 0.05) about the effects of DEX on PPCs (including hypoxemia, atelectasis and lung infection) in elderly patients undergoing spinal surgery. However, alien results in other studies still existed. In 2016, Su Hyun Lee [thirteen] showed that patients with moderate COPD undergoing lung cancer surgery in DEX grouping had fewer incidence of PPCs, including atelectasis (0% vs. 16%, P = 0.110), focal lung infiltration (four% vs. 8%, P > 0.99)and acute lung injury (0% vs. 4%, P > 0.99) by improving oxygenation and lung mechanics, but there was no statistical difference (P > 0.05). In 2016, Rabie Soliman [15] found in high-gamble patients undergoing aortic vascular surgery, DEX can not reduce the occurrence of PPCs (including infection and edema, P = 0.999), either. In 2017, Xue Li [17] found that the incidence of PPCs (including pulmonary infection, pneumothorax and pleural effusion) tended to be lower in the DEX grouping than in the command grouping (OR 0.51, 95% CI 0.26 to one.00; p = 0.050) in elderly patients after cardiac surgery. In 2019, Li-Yun Zhang [18] indicated that at that place were no significant differences in PPCs(including atelectasis, pneumonia and air leak) betwixt DEX and command groups (P > 0.05) in patients receiving robotic-assisted thoracic surgery.
In addition, our survey revealed the most common PPCs was respiratory infection, registering 14(17.5%) patient in DEX group in comparison with 19 (23.8%) in placebo group. Occurrence of postoperative respiratory infection was the same with the retrospective study in 2015 virtually 482 patients undergoing oral cancer surgery with tracheotomy [6] and the retrospective analysis of 331 cases after oral and maxillofacial surgery with or without free flap structure in 2017 [22]. Previous studies had showed that multiple variables including advanced historic period, male person sexual practice, poor underlying medical condition, surgery location, a higher American Social club of Anesthesiologists (ASA) grade, tracheotomy and reintubation were associated with an increased hazard of postoperative pneumonia [22]. All our patients were older than 51 years and underwent tracheotomy, and almost of our patients were male (63.8% vs. 36.3, 66.iii% vs. 33.8%, respectively), which could have been responsible for the high incidence of postoperative pneumonia in our written report. Simply, the incidence of the other PPCs (included respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, aspiration pneumonitis, pulmonary edema, pulmonary embolism, and acute respiratory distress syndrome) in our written report was low. This was different from the latest 2 studies in JAMA 2019, which showed that respiratory failure was the most common PPC [ii, three].
Oral and maxillofacial surgery was a specific surgical sub-cohort within head and cervix surgery, which was considered high take a chance of PPCs [23]. The fibular free flap was one of the most frequently used free flaps in oral and maxillofacial surgery, which was used for reconstruction of bony or composite defects [v]. In oral and maxillofacial surgery, patients after surgery might exist highly impacted with after touch owing to swallowing and cough, due to the body specific stance, organs of swallowing and breathing. This hinders airway which might cause the incident of PPCs equally an consequence [24]. Moreover, this type of surgery had long surgical fourth dimension or mechanical ventilation time (mostly more than 3 h), which might cause ventilation induced lung injury (VILI) [25], and had limb ischemia-reperfusion injury due to the apply of the tourniquet in the thigh area, which might induce remote lung impairment [26]. Except that, after the type of surgery, due to the microvascular reconstruction technique in the cervix region, patients are required to stay lying in bed restraining lots of neck movement for at least 3 days after surgery, which might bring about respiratory muscle complications and rima oris ejection and even PPCs [27]. Thus, 1 might wait a high rate of PPCs after oral and maxillofacial surgery, which had been proven in previous studies [5, seven, 8]. In our study, PPCs adult in 40.0% (32 of 80) of oral and maxillofacial surgery with tracheotomy patients in the placebo group, largely in agreement with the prospective, randomized, controlled trial written report about major caput and neck surgery with tracheostomy (47%) [ix], simply much higher than the retrospective analysis of 648 cases about major oral and maxillofacial surgery with microvascular reconstruction (18.eight%) [v]. To this conflict, we considered the risk of tracheotomy might be the main crusade, but this needed more proofs. On the other mitt, our data further supported the show that oral and maxillofacial surgery was associated with a loftier risk of PPCs.
Although DEX was generally well tolerated, it could crusade concentration related adverse circulatory furnishings (e.yard. bradycardia and hypotension) [28]. Even so, the human relationship between the dose use/ the fashion of DEX administration (a single-bolus injection, a continuous infusion, or both in combination) and cardiac side-effects had not been established [12]. In our study, the median (IQR) of age of the two groups was 59 (55,65) and 62 (56,67) years, so in consideration of concentration related agin circulatory effects for elderly patients, we chose a 0.4 μg/kg infusion over 10 min, followed by a dose of 0.4 μg/kg/h to maintain the anesthesia. The similar low DEX infusion dosing could be found in many other studies [10, 29–31]. And our study also indicated that this dose of DEX continuous infusion did not increase the prevalence of bradycardia or hypotension, so nosotros idea that our DEX dose was proper for safety evaluation.
A systematic review and meta-analysis in BMJ indicated that postoperative pulmonary complications typically took place within the offset calendar week after surgery [32], and it had been proved that the fourth dimension between surgery and the first postoperative pulmonary complication was about three (two to 6) days [33]. These conclusions were similar in our study, in which the kickoff fourth dimension of diagnosis of PPCs was four (2 to 5) days in DEX grouping and 3 (ii to 5) days in control group. We assumed that DEX infusion could convalesce the lung injury during the infusion time past reducing inflammation and stress, as well as protecting the immune function [34]. Just the effects of DEX on clinical outcomes, such equally PPCs, would gradually emerge after DEX termination. There had been a keen number of clinical studies which demonstrated that perioperative DEX administration had benefits near long term (e.g. postoperative thirty days [17], fifty-fifty 3 years [35]) clinical outcomes. In consequence, nosotros chose a time frame of postoperative seven days most primary outcome assessment. And this could explain why the Kaplan-Meier analysis of the present RCT the virtually profound difference between groups occurred later on the postoperative solar day iv (long afterward DEX termination).
Information technology started becoming articulate that in that location were dissimilarity between those above surveys looking dorsum to the overview of contrast and similarities, including the study population, the surgery type, the diagnostic criteria of PPCs, the observation time of PPCs, the dose of DEX, and so on. Therefore, our study was the showtime prospective clinical trial most the relationship betwixt DEX and PPCs in patients undergoing oral and maxillofacial surgery with microvascular reconstruction and tracheotomy.
So far, the evidence on the accurate mechanisms of the effects about DEX on PPCs remained poorly understood, because of the circuitous etiology and pathophysiology and dissimilar diagnosis criteria of PPCs. A number of previous animal and clinical studies had tried to reveal the various mechanisms which might contribute to the lung protective event of DEX. Commencement, DEX, as a new highly selective αii adrenergic receptor agonist, could alleviate lung injury by improving ventilation/perfusion ratio and oxygenation past straight stimulating α2B receptors in lung vascular smooth muscles [14]. 2nd, DEX had straight protective effects on airway. An animal experiment in dogs reported that DEX had a bronchodilator effect in histamine-mediated bronchospasm [36], as well as a report in guinea squealer improved that DEX had a direct airway smooth muscle consequence and an underlying mechanism for cough suppression past inhibiting acetylcholine releasing from cholinergic nerves [37]. 3rd, inflammation was an important crusade of lung injury. Various studies had showed that DEX could suppress systemic inflammatory processes by downregulation the signaling pathway of HMGB1-TLR4-MyD88-MARK- NF-κB and inflammatory mediators of IL-1, IL-4, IL-6, IL-8 and TNF-α, etc. [34, 38]by activating αii adrenergic receptors and stimulating the vagus nerve via a vagal and α7 nicotinic acetylcholine receptor-dependent machinery [39]. 4th, DEX had been demonstrated to have lung protective effects by reducing dead space ventilation, increasing dynamic compliance [13], and so this signal as well might be one of the reasons why DEX could decrease PPCs in our study. Fifth, propofol, which was the main anesthetic during functioning in anesthesia maintain menses in our study, was reported to have a college charge per unit of PPCs compared with inhaled anesthetics sevoflurane [twoscore]. In our study, the amount of propofol was significantly lower in the DEX group than in the placebo group, and so we might conclude that, afterwards intravenous infusion of DEX, the decreasing demand for propofol had a beneficial effect of reducing the incidence of PPCs. Six, our results showed a pregnant difference in intraoperative remifentanil consumption between the two groups, which could be explained that the lower opioid consumption in the DEX group was caused by the analgesic effect of DEX. Remifentanil was an ultra-short-acting, potent opioid analgesic. Previous studies showed that remifentanil could attenuate inflammation and astute lung injury through signaling pathway [41, 42]. So, in our report, the lower occurrence of PPCs in DEX group might be in connection with the lessened corporeality of remifentanil. Seven, Ahmed Hasanin in 2018 [43] supposed in his paper that the improvement of lung mechanics might be due to the potential better sedation state of DEX administration to have better relaxation of the chest wall, but this needed further proofs. However, overall speaking, all those above assumptions required further evaluation in more studies with college level of evidence.
Apart from DEX-induced improvements in PPCs and postoperative length of stay in hospital, our study as well found that on the outset day after oral and maxillofacial surgery, DEX alleviated the subjective pain in both oral and maxillofacial expanse and fibular area, and increased the objective sleep fourth dimension. These results were like with the clinical trial in Lancet past Su Xian in 2016 [10]. The analgesia issue of DEX was worked past interim on the α2 adrenergic receptors in the spinal string [44]. The hypnotic properties of DEX was exerted by activating the endogenous slumber-promoting pathway and producing a stage II not-rapid eye motion slumber-like country [45].
Besides, previous study had confirmed that safety DEX significantly decreased the occurrence of delirium during the first 7 days afterward not-cardiac surgery [10]. Still, in our study, we constitute that patients in the DEX group had less delirium incidence than patients in the placebo grouping (one.3% vs. 5.0%; RR 0.250, CI 0.029–2.188; P = 0.173), but without statistical departure. Nosotros inferred the reason might be our sample size was not big plenty considering the low incidence of postoperative delirium in our study population.
The survey had a lot of limitations. (one) The study was simply designed to investigate differences in postoperative clinical exercise (incidence of PPCs), but lack of inquiry of the effect of DEX on biological markers (in plasma or bronchoalveolar lavage fluid) about lungs damages and indicators almost respiratory dynamics throughout the perioperative time. (2) Regarding the high hospital cost, serum concentration of DEX wasn't calculated. (iii) This trial simply studied 1 kind of transfusion speed and 1 administration mode of DEX, so different transfusion speeds and unlike administration ways should exist farther investigated. (4) The finding of ROC bend analysis was not that robust, then the finding of the dose-effect relationship between DEX and PPCs tin be considered valid only for this specific clinical setting. (5) Since our study was the beginning clinical trial to evaluate the influence of DEX on the incidence of PPCs in patients undergoing oral and maxillofacial surgery, and we did not behave a airplane pilot study, the sample size calculation which we referred to the relevant data of patients undergoing spinal surgery might not be very accurate. Fortunately, the positive result was obtained in this study. Notwithstanding, futurity larger sample size clinical trials are needed to verify our findings. (6) Due to the complex and various definition of PPCs and the hospital where we carried out this report is a specialized Stomatological hospital, the improper estimation of PPCs did exist. Therefore, further research in the future volition take the above factors into account.
Conclusion
For patients undergoing oral and maxillofacial surgery with fibular complimentary flap reconstruction and tracheotomy who were at intermediate or high take chances of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7 days subsequently surgery and shorten the length of hospital stay later surgery, but did non increase the prevalence of bradycardia or hypotension. In consideration of the limitations in our report, a larger sample size may be required to verify the difference in the future.
Supplementary information
Acknowledgements
Not applicative.
Consort guidelines
This manuscript reporting adhered to CONSORT guidelines.
Abbreviations
| PPCs | Postoperative pulmonary complications |
| DEX | Dexmedetomidine |
| RR | Relative take a chance |
| CI | Confidence interval |
| ARISCAT | Assess Respiratory Risk in Surgical Patients in Catalonia |
| AECOPD | astute exacerbation of chronic obstructive pulmonary disease |
| TOF | Train-of-Four |
| BIS | Bispectral Alphabetize |
| EtCO2 | End-tidal carbon dioxide concentration |
| TCI | Target-controlled infusion |
| FiO2 | Fraction of inspiration Otwo |
| PEEP | Positive cease-expiratory force per unit area |
| HES | Hydroxyethyl starch |
| PACU | Postoperative intendance unit |
| NRS | Numeric rating scale |
| VILI | Ventilation induced lung injury |
| ASA | American Society of Anesthesiologists |
| CAM-ICU | Confusion Cess Method for the ICU |
| ROC | Receiver operating characteristic |
| AUC | Area under the ROC curve |
| IQR | Interquartile range |
| BMI | Torso mass index |
| NYHA | New York Center Association |
| SpO2 | Oxygen saturation as measured past pulse oximetry |
| Hb | Hemoglobin |
| COPD | Chronic obstructive pulmonary affliction |
Authors' contributions
YL, DZ and FH contributed to acquisition of data. YL and XDY contributed to statistical analysis. YL was the major contributor in drafting the manuscript. XZ and XDY critically revised the manuscript and approved the version to be submitted. The authors read and approved the concluding manuscript.
Funding
This work was supported past National Science and Technology Major Projection (2018ZX10101004), National Natural Science Foundation of Mainland china (81372043), Beijing Natural Scientific discipline Foundation (7162199) and Interdisciplinary medicine seed Fund of Peking University, (BMU2018MX014). All the funding bodies had no office in written report design, information collection and analysis, conclusion to publish or preparation of the manuscript.
Availability of data and materials
The datasets generated and/or analyzed during the current study will be available from the corresponding author on a reasonable request.
Ethics approval and consent to participate
Ethical approval was received from the Biomedical Ideals Committee of Peking Academy Infirmary of Stomatology (Number: PKUSSIRB-201735060) in January 26, 2018. Written informed consent was obtained from all participating patients or their next of kin or legal representative who must understand the recruiter's clarification of the trial.
Consent for publication
Not applicative.
Competing interests
The authors declare that they have no competing interests.
Footnotes
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Contributor Information
Xi Zhu, Email: moc.qq@8977193.
Xudong Yang, Email: moc.361@gnoduxgnayqk.
Supplementary information
Supplementary information accompanies this newspaper at 10.1186/s12871-020-01045-three.
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Articles from BMC Anesthesiology are provided here courtesy of BioMed Central
Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7251859/
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