Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, Hefei, China.
Department of Anesthesiology, University of Utah, Salt Lake City.
JAMA Netw Open. 2021 Oct 1;4(10):e2128886. doi: 10.1001/jamanetworkopen.2021.28886.
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. TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR1800017232.
重要性:术后肠梗阻在腹部手术后很常见,一些小型临床研究报告称,术中给予右美托咪定可能与改善术后胃肠道功能有关。然而,研究结果并不一致,且研究样本较小。需要进一步研究术中给予右美托咪定对老年患者腹部手术后胃肠道功能的影响。 目的:评估在接受腹部手术的老年患者中,与安慰剂相比,术中静脉给予右美托咪定对术后胃肠道功能的影响。 设计、地点和参与者:这是一项多中心、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(牵头单位)和安徽省的 12 家其他三级医院进行。共纳入 808 名年龄在 60 岁或以上、预计手术时间为 1 至 6 小时的患者。该研究于 2018 年 8 月 21 日至 2019 年 12 月 9 日进行。 干预措施:右美托咪定输注(负荷剂量 0.5μg/kg 持续 15 分钟,随后维持剂量 0.2μg/kg/小时)或安慰剂输注(生理盐水)。 主要结局和测量指标:主要结局为首次排气时间。次要结局为术后胃肠道功能,采用 I-FEED(摄入、恶心、呕吐、体格检查和症状持续时间)评分系统评估,首次排便时间、首次口服进食时间、谵妄发生率、疼痛评分、睡眠质量、术后恶心和呕吐、住院费用和住院时间。 结果:在纳入的 808 名患者中,404 名随机分配接受术中右美托咪定,404 名随机分配接受安慰剂。共有 133 名患者(右美托咪定组 60 名,安慰剂组 73 名)因方案偏离而被排除,675 名患者(右美托咪定组 344 名,安慰剂组 331 名;平均[标准差]年龄 70.2[6.1]岁;445 名男性[65.9%])被纳入意向治疗分析。与安慰剂组相比,右美托咪定组首次排气时间(中位数 65 小时[IQR 48-78 小时]比 78 小时[62-93 小时],P < .001)、首次排便时间(中位数 85 小时[IQR 68-115 小时]比 98 小时[IQR 74-121 小时],P = .001)和住院时间(中位数 13 天[IQR 10-17 天]比 15 天[IQR 11-18 天],P = .005)更短。术后胃肠道功能(通过 I-FEED 评分评估)和谵妄发生率在右美托咪定组和对照组之间相似(例如,248 名患者[72.1%]与 254 名患者[76.7%],分别有 I-FEED 评分表明术后胃肠道功能正常;18 名患者[5.2%]与 12 名患者[3.6%]在术后第 3 天出现谵妄)。 结论和相关性:在这项随机临床试验中,术中给予右美托咪定可缩短腹部手术后首次排气、首次排便和住院时间。这些结果表明,这种治疗方法可能是增强老年患者术后胃肠道功能恢复的可行策略。 试验注册:中国临床试验注册中心标识符:ChiCTR1800017232。
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