术中使用右美托咪定对老年患者行腹部手术后胃肠功能恢复的影响：一项随机临床试验

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术中使用右美托咪定对老年患者行腹部手术后胃肠功能恢复的影响：一项随机临床试验                                

贵州医科大学  麻醉与心脏电生理课题组

翻译：吴学艳  编辑：马艳燕  审校：曹莹

背景 患者行腹部手术后常并发肠梗阻，少许临床研究报道，术中应用右美托咪定可能改善术后胃肠功能。然而，研究结果报道并不一致，且样本量较少。术中使用右美托咪定对患者术后胃肠功能恢复的影响有待进一步研究。 

目的 评价老年患者行腹部手术过程中静脉泵注右美托咪定和安慰剂对术后胃肠功能的影响。 

设计、环境、参与者 此项多中心、双盲、安慰剂对照的随机临床试验在中国安徽医科大学第一附属医院及安徽省其他12家三级医院进行。试验纳入808例患者，年龄≥60岁，计划行择期手术；预计手术持续时长为1-6小时；该研究于2018年8月21日-2019年12月9日进行。 

 干预措施 右美托咪定组，术中持续静脉输注右美托咪定(负荷剂量0.5ug/kg输注时长＞15min，随后以0.2ug/Kg/h维持)，安慰剂组(输注生理盐水)。 

 主要观察指标及实施措施 主要观察指标为患者首次排气时间；次要观察指标为采用I-FEED评分系统评估术后胃肠功能(摄入量、恶心、呕吐及症状持续时间)、首次排便时间、首次进食时间、谵妄发生率、疼痛评分、睡眠质量、术后恶心、呕吐、住院费用和住院时长。 

 结果 研究纳入808例患者，随机分为两组，404例患者术中接受右美托咪定治疗，404例接受安慰剂治疗；因试验方案偏差排除133例患者(右美托咪定组60例，安慰剂组73例)。675例患者中(右美托咪定组344例，安慰剂组331例；平均年龄SD 70.2±6.1岁；445例[65.9%]为男性患者）纳入方案分析。右美托咪定组首次排气时间明显缩短，首次排气时间（右美托咪定组中位数为65h，[IQR,48-78h]，安慰剂组中位数为78h[IQR,62-93h];P＜0.001)；首次排便时间(右美托咪定组中位数为85h,[IQR,68-115h]；安慰剂组中位数为98h, [IQR, 74 -121h] p=0.001)和住院时长(右美托咪定组中位数为13天[IQR，10-17天]，安慰剂组中位数为15天[IQR，11-18天];p=0.005)。右美托咪定组与对照组对术后胃肠功能的影响(采用I-FEED评分衡量)和妄想发生率相似，两组术后胃肠功能正常患者分别为(右美托咪定组248例[72.1%]，安慰剂组254例[76.7%]；术后第3天出现谵妄发生率为，右美托咪定组术18例[5.2%]，安慰剂组12例[3.6%]）。    

 结论和意义 在此项随机临床试验中，术中输注右美托咪定缩短腹部手术患者术后首次排气、首次排便及住院时间。研究结果表明，该疗法可能是促进老年人术后胃肠功能恢复的一种可行性策略。 

原始文献来源：  Lu Y, Fang PP, Yu YQ, et al. Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial[J]. JAMA Netw Open. 2021 Oct 1;4(10):e2128886. DOI:10.1001/jamanetworkopen.2021.28886. 

   英文原文 

Effect of Intraoperative Dexmedetomidine on Recovery of Gastrointestinal Function After Abdominal Surgery in Older Adults: A Randomized Clinical Trial Abstract Importance: Postoperative ileus is common after abdominal surgery, and small clinical studies have reported that intraoperative administration of dexmedetomidine may be associated with improvements in postoperative gastrointestinal function. However, findings have been inconsistent and study samples have been small. Further examination of the effects of intraoperative dexmedetomidine on postoperative gastrointestinal function is needed. 

Objective: To evaluate the effects of intraoperative intravenous dexmedetomidine vs placebo on postoperative gastrointestinal function among older patients undergoing abdominal surgery. 

Design, setting, and participants: This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at the First Affiliated Hospital of Anhui Medical University in Hefei, China (lead site), and 12 other tertiary hospitals in Anhui Province, China. A total of 808 participants aged 60 years or older who were scheduled to receive abdominal surgery with an expected surgical duration of 1 to 6 hours were enrolled. The study was conducted from August 21, 2018, to December 9, 2019. 

Interventions: Dexmedetomidine infusion (a loading dose of 0.5 μg/kg over 15 minutes followed by a maintenance dose of 0.2 μg/kg per hour) or placebo infusion (normal saline) during surgery. 

Main outcomes and measures: The primary outcome was time to first flatus. Secondary outcomes were postoperative gastrointestinal function measured by the I-FEED (intake, feeling nauseated, emesis, physical examination, and duration of symptoms) scoring system, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs, and hospital length of stay. 

Results: Among 808 patients enrolled, 404 were randomized to receive intraoperative dexmedetomidine, and 404 were randomized to receive placebo. In total, 133 patients (60 in the dexmedetomidine group and 73 in the placebo group) were excluded because of protocol deviations, and 675 patients (344 in the dexmedetomidine group and 331 in the placebo group; mean [SD] age, 70.2 [6.1] years; 445 men [65.9%]) were included in the per-protocol analysis. The dexmedetomidine group had a significantly shorter time to first flatus (median, 65 hours [IQR, 48-78 hours] vs 78 hours [62-93 hours], respectively; P < .001), time to first feces (median, 85 hours [IQR, 68-115 hours] vs 98 hours [IQR, 74-121 hours]; P = .001), and hospital length of stay (median, 13 days [IQR, 10-17 days] vs 15 days [IQR, 11-18 days]; P = .005) than the control group. Postoperative gastrointestinal function (as measured by the I-FEED score) and delirium incidence were similar in the dexmedetomidine and control groups (eg, 248 patients [72.1%] vs 254 patients [76.7%], respectively, had I-FEED scores indicating normal postoperative gastrointestinal function; 18 patients [5.2%] vs 12 patients [3.6%] had delirium on postoperative day 3).

Conclusions and relevance: In this randomized clinical trial, the administration of intraoperative dexmedetomidine reduced the time to first flatus, time to first feces, and length of stay after abdominal surgery. These results suggest that this therapy may be a viable strategy to enhance postoperative recovery of gastrointestinal function among older adults.