Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial
{"title":"Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial","authors":"Yue Yun, L. Pei","doi":"10.4103/2455-7765.173005","DOIUrl":null,"url":null,"abstract":"Background: Favorable quality of recovery from general anesthesia in neurosurgical patients is an important goal for anesthesiologists. Dexmedetomidine is an emerging anesthetic adjuvant characterized by a stable hemodynamic recovery period, and neither its sedative nor analgesic effects influence evaluation of neurological function. We hypothesize that a bolus injection of low-dose dexmedetomidine during general anesthesia within minutes before the end of surgery in patients undergoing craniotomy can improve the quality of recovery from general anesthesia, thereby benefitting the evaluation of early-stage neurological function after surgery. Methods/Design: Patients with supratentorial tumors who have undergone craniotomy under general anesthesia at the Department of Neurosurgery, First Affiliated Hospital of China Medical University are included in this randomized controlled trial. A sample size of 150 patients is needed. Patients in the experimental group are randomly assigned to receive intravenous bolus injection of low- and medium-dose dexmedetomidine (0.4 and 0.8 ΅g/kg, respectively). Patients in the control group receive equal doses of physiological saline. The primary outcome of the study is the quality of recovery from general anesthesia, including awakening time, degree of sedation, spontaneous breathing recovery time, and coughing and bucking at the time of tracheal extubation. Secondary outcomes include postoperative analgesic effects, hemodynamic indices, anesthesia time, operation time, and neurological function assessment. Discussion: The results from this trial will provide optimal evidence for intravenous bolus injections of dexmedetomidine at a dose that can improve the quality of recovery from general anesthesia after craniotomy for supratentorial tumors. Trial registration: ClinicalTrails.gov identifier: NCT02007798; registered on 6 December 2013.","PeriodicalId":8515,"journal":{"name":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","volume":"2 1","pages":"18 - 24"},"PeriodicalIF":0.0000,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asia Pacific Journal of Clinical Trials: Nervous System Diseases","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.4103/2455-7765.173005","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Favorable quality of recovery from general anesthesia in neurosurgical patients is an important goal for anesthesiologists. Dexmedetomidine is an emerging anesthetic adjuvant characterized by a stable hemodynamic recovery period, and neither its sedative nor analgesic effects influence evaluation of neurological function. We hypothesize that a bolus injection of low-dose dexmedetomidine during general anesthesia within minutes before the end of surgery in patients undergoing craniotomy can improve the quality of recovery from general anesthesia, thereby benefitting the evaluation of early-stage neurological function after surgery. Methods/Design: Patients with supratentorial tumors who have undergone craniotomy under general anesthesia at the Department of Neurosurgery, First Affiliated Hospital of China Medical University are included in this randomized controlled trial. A sample size of 150 patients is needed. Patients in the experimental group are randomly assigned to receive intravenous bolus injection of low- and medium-dose dexmedetomidine (0.4 and 0.8 ΅g/kg, respectively). Patients in the control group receive equal doses of physiological saline. The primary outcome of the study is the quality of recovery from general anesthesia, including awakening time, degree of sedation, spontaneous breathing recovery time, and coughing and bucking at the time of tracheal extubation. Secondary outcomes include postoperative analgesic effects, hemodynamic indices, anesthesia time, operation time, and neurological function assessment. Discussion: The results from this trial will provide optimal evidence for intravenous bolus injections of dexmedetomidine at a dose that can improve the quality of recovery from general anesthesia after craniotomy for supratentorial tumors. Trial registration: ClinicalTrails.gov identifier: NCT02007798; registered on 6 December 2013.