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Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.

ABSTRACT: BACKGROUND:Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an ?2-adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about 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 total 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). 0.4 ?g/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 ?g/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7?days after surgery. RESULTS:The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7?days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P?=?0.017). In the first 7?days after 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 prone to occur PPCs (Cox regression, P?=?0.025, HR?=?0.516). When the total dose of DEX was more than 328??g, the patients were unlikely to have 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.

SUBMITTER: Liu Y

PROVIDER: S-EPMC7251859 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.

Liu Yun Y Zhu Xi X Zhou Dan D Han Fang F Yang Xudong X

BMC anesthesiology 20200527 1

<h4>Background</h4>Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an α<sub>2</sub>-adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about 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 o ...[more]

PMID: 32460699

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Project description:ImportanceParamedian forehead flaps are commonly used to reconstruct facial defects caused by skin cancers. Data are lacking on the complications from this procedure, postoperative outcomes, and association of cancer diagnosis with rate of deep venous thrombosis (DVT).ObjectivesThe primary objective was to determine complication rates after paramedian forehead flap reconstruction for defects resulting from resection of facial cancers; and the secondary objective was to determine patient factors and complications that are associated with readmission.Design, setting, and participantsRetrospective cohort study of patients who underwent paramedian forehead flap reconstruction for skin cancer reconstruction from January 1, 2007, through December 31, 2013. Data analysis took place between October 1, 2017, and June 1, 2018.Main outcomes and measuresComplication rates including DVT, emergency department visits, and hospital readmissions.ResultsA total of 2175 patient were included in this study; mean (SD) age, 70.3 (13.4) years; 1153 (53.5%) were men. Postoperative DVT occurred in 10 or fewer patients (≤0.5%); postoperative bleeding in 30 (1.4%), and postoperative infection in 63 (2.9%). Most patients went home on the day of surgery (89.6%; n = 1949), while 10.4% stayed one or more days in the hospital (n = 226). Overnight admission was associated with tobacco use (odds ratio [OR], 1.65; 95% CI, 1.11-2.44), hypothyroidism (OR, 1.93; 95% CI, 1.10-3.39), hypertension (OR, 1.82; 95% CI, 1.29-2.57), ear cartilage graft (OR, 2.20; 95% CI, 1.51-3.21), and adjacent tissue transfer (OR, 1.88; 95% CI, 1.33-2.67). Risk factors strongly associated with immediate return to the emergency department or readmission within 48 hours of surgery included postoperative bleeding (OR, 13.05; 95% CI, 4.24-40.16), neurologic disorder (OR, 4.11; 95% CI, 1.12-15.09), and alcohol use (OR, 7.70; 95% CI, 1.55-38.21).Conclusions and relevanceIn this study, the most common complication of paramedian forehead flap reconstruction was infection. Risk factors for readmission included development of postoperative bleeding, having a neurologic disorder, and alcohol use. Deep venous thrombosis was a rare complication. Because bleeding is a more common complication in this patient population, discretion should be used when deciding to administer anticoagulation medication to low- to medium-risk patients prior to surgery.Level of evidenceNA.

Project description:IntroductionThe transition of acute to chronic postoperative pain (CPP) remains a significant burden to the rehabilitation of patients. The research for adjuvants to prevent CPP continues; among others, dexmedetomidine and lidocaine seem promising agents.MethodsThis is a long-term follow-up of a randomized, placebo-controlled, double-blind study on women who underwent open abdominal gynecological surgery and received dexmedetomidine or lidocaine or placebo infusion perioperatively (n = 81). The effect of these adjuvants on the development of CPP and neuropathic pain was assessed during a 12-month follow-up. Eighty-one (81) women ASA I-II, aged between 30 and 70 years, were randomly assigned to receive either dexmedetomidine (DEX group) or lidocaine (LIDO group) or placebo (CONTROL group) perioperatively. Before anesthesia induction, all patients received a loading intravenous dose of either 0.6 μg/kg dexmedetomidine or 1.5 mg/kg lidocaine or placebo, followed by 0.6 μg/kg/h dexmedetomidine or 1.5 mg/kg/h lidocaine or placebo until last suture. Patients were followed up to obtain the long-term outcomes at 3, 6, and 12 months. At these time-points, pain intensity was assessed with the Numerical Rating Scale, (NRS: 0-10) and the development of neuropathic elements with the Douleur Neuropathique 4 (DN4) score. Prognostic parameters that could affect chronic pain and its components were also identified.ResultsData from 74 women were analyzed. Dexmedetomidine significantly reduced NRS scores comparing to placebo at 3 months (p = 0.018), while at 6 months, lidocaine was found superior to placebo (p = 0.02), but not to dexmedetomidine, in preventing neuropathic pain (DN4 < 4). Regarding secondary endpoints, higher NRS cough scores at 48 h were associated with statistically significant NRS and DN4 scores at 3, 6, and 12 months (p < 0.02). At 6 months, a statistically significant correlation was also found between higher NRS values and older age (p = 0.020).ConclusionsDexmedetomidine was superior to placebo regarding the duration and severity of CPP, while lidocaine exhibited a protective effect against neuropathic elements of CPP.Trial registrationClinicalTrials.gov identifier, NCT03363425.

Dataset Information

Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.

Publications

Dexmedetomidine for prevention of postoperative pulmonary complications in patients after oral and maxillofacial surgery with fibular free flap reconstruction:a prospective, double-blind, randomized, placebo-controlled trial.

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