Use of low-dose dexmedetomidine in general anesthesia improves postoperative recovery of patients with supratentorial tumors: study protocol for a randomized controlled trial

Yue Yun, L. Pei
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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.
在全身麻醉中使用低剂量右美托咪定可改善幕上肿瘤患者术后恢复:一项随机对照试验的研究方案
背景:神经外科患者全身麻醉后良好的恢复质量是麻醉医师的一个重要目标。右美托咪定是一种新兴的麻醉佐剂,其特点是血流动力学恢复期稳定,其镇静和镇痛作用均不影响神经功能的评价。我们假设开颅手术患者在手术结束前几分钟在全麻状态下静脉注射低剂量右美托咪定可以提高全麻恢复质量,从而有利于术后早期神经功能的评估。方法/设计:选取在中国医科大学第一附属医院神经外科全麻下行开颅术的幕上肿瘤患者为随机对照试验。需要150名患者的样本量。实验组患者随机接受低、中剂量右美托咪定静脉滴注(分别为0.4、0.8 ΅g/kg)。对照组给予等量生理盐水。本研究的主要观察指标是全麻恢复质量,包括苏醒时间、镇静程度、自主呼吸恢复时间、拔管时的咳嗽和屈曲。次要结局包括术后镇痛效果、血流动力学指标、麻醉时间、手术时间、神经功能评价。讨论:本试验的结果将为静脉注射右美托咪定提供最佳证据,该剂量可以提高幕上肿瘤开颅术后全身麻醉的恢复质量。试验注册:ClinicalTrails.gov标识符:NCT02007798;于2013年12月6日注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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