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术前低剂量和高剂量普瑞巴林与气管插管心血管反应:一项在中国进行的前瞻性、随机、单盲、对照研究。

Preoperative Low-dose and High-dose Pregabalin and Cardiovascular Response to Endotracheal Intubation: A Prospective, Randomized, Single-blind, Controlled Study in China.

机构信息

Department of Anesthesiology, Qingpu Branch of Zhongshan Hospital affiliated with Fudan University, Shanghai, China.

Department of Anesthesiology, Zhongshan Hospital affiliated with Fudan University, Shanghai, China.

出版信息

Clin Ther. 2019 Jan;41(1):68-77. doi: 10.1016/j.clinthera.2018.11.006. Epub 2018 Dec 13.

Abstract

PURPOSE

A prospective, randomized, single-blind, controlled clinical study was designed to evaluate the efficacy and tolerability of preoperative pregabalin on cardiovascular response to laryngoscopy and endotracheal intubation.

METHODS

Patients aged 18-60 years with an American Society of Anesthesiologists scale score of I or II were recruited and randomly allocated to receive placebo (control), low-dose (150-mg) pregabalin, or high-dose (300-mg) pregabalin. The medications were orally administered 1 hour before general anesthesia. Heart rate, systolic and diastolic blood pressures, and mean arterial blood pressure were measured and recorded prior to the administration of placebo or pregabalin; before endotracheal intubation; and at 0, 1, 3, 5, 7, and 10 minutes after intubation. The sedation score was evaluated 1 hour after the administration of placebo or pregabalin.

FINDINGS

A total of 90 patients were enrolled (n = 30 per group). Pregabalin (150 or 300 mg) was associated with reduced blood pressure fluctuations after intubation, but with no significant differences between the 2 dose groups. Pregabalin was associated with an inhibitory effect on heart rate fluctuations and reduced hemodynamic complications after intubation, in a dose-dependent manner, but no effect on the required perioperative opioid dosage was found. Both doses were effective in reducing preoperative anxiety, but visual analog scale pain scores at 1 hour after surgery were reduced only in limb and spine as well as abdominal surgeries. A pregabalin-related adverse reaction was dizziness, which was observed at 1 hour after surgery in both groups.

IMPLICATIONS

In this study, high-dose (300-mg) pregabalin effectively attenuated cardiovascular response after endotracheal intubation. ClinicalTrials.gov identifier: NCT03456947.

摘要

目的

设计了一项前瞻性、随机、单盲、对照临床试验,旨在评估术前普瑞巴林对喉镜和气管插管引起的心血管反应的疗效和耐受性。

方法

招募了年龄在 18-60 岁之间、美国麻醉医师协会(ASA)评分 I 或 II 级的患者,并随机分配接受安慰剂(对照组)、低剂量(150mg)普瑞巴林或高剂量(300mg)普瑞巴林。药物在全身麻醉前 1 小时口服。在给予安慰剂或普瑞巴林前、气管插管前、插管后 0、1、3、5、7 和 10 分钟测量和记录心率、收缩压、舒张压和平均动脉压。在给予安慰剂或普瑞巴林后 1 小时评估镇静评分。

结果

共纳入 90 例患者(每组 30 例)。普瑞巴林(150 或 300mg)与插管后血压波动减少有关,但两组之间无显著差异。普瑞巴林与心率波动抑制作用有关,并以剂量依赖性方式减少插管后血流动力学并发症,但对围手术期阿片类药物剂量无影响。两种剂量均有效降低术前焦虑,但仅在四肢、脊柱和腹部手术中,术后 1 小时视觉模拟评分疼痛减轻。普瑞巴林相关不良反应为头晕,两组均在术后 1 小时出现。

结论

在这项研究中,高剂量(300mg)普瑞巴林有效减轻了气管插管后的心血管反应。临床试验注册号:NCT03456947。

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