术中右美托咪定输注对心脏瓣膜手术后成人患者谵妄的影响：一项随机、双盲、安慰剂对照研究方案。

Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study.

机构信息

Department of Anesthesiology, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, No. 167 North Lishi Road, Xicheng District, Beijing, China.

Department of Anesthesiology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, No. 6, 7 Branch Road, Panxi, Jiangbei District, Chongqing, China.

出版信息

Trials. 2020 Jul 14;21(1):645. doi: 10.1186/s13063-020-04574-x.

DOI:10.1186/s13063-020-04574-x

PMID:32665034

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7362632/

Abstract

BACKGROUND

Delirium is an acute status of brain dysfunction that commonly occurs in patients who have undergone cardiac surgery, and increases morbidity and mortality. It is associated with risk factors, such as older age, use of narcotics, cardiopulmonary bypass, and hypothermia. Dexmedetomidine infusion might exert a neuroprotective effect. However, the effect of perioperative administration of dexmedetomidine on the incidence of postoperative delirium (POD) in patients undergoing cardiac or non-cardiac surgery is yet controversial. The present study aimed to reveal the effect of intraoperative dexmedetomidine administration on the incidence of delirium in adult patients following cardiac surgery.

METHODS

This single-center, randomized, double-blinded, and placebo-controlled trial consisted of 652 patients randomly divided into two groups: dexmedetomidine and placebo. 0.6 μg/kg dexmedetomidine will be infused 10 min after central vein catheterization, followed by a continuous infusion at a speed of 0.4 μg/kg/h until the end of surgery in the dexmedetomidine group, while normal saline will be administered at the same rate in the placebo group. The primary outcome is the incidence of POD during the first 7 days post-surgery. The secondary outcomes include duration of mechanical ventilation after surgery, duration of stay in the intensive care unit and the hospital after surgery, incidence of hypotension during or after dexmedetomidine infusion, acute kidney injury and sudden arrhythmia during the hospital stay postoperatively, and all-cause mortality in 30 and 90 days after surgery, respectively.

DISCUSSION

This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences Fuwai Hospital on 6 March 2019 (2019-1180). The results will be disseminated at academic conferences and submitted to peer-reviewed publications. Either positive or negative results will provide guidance for clinical practice.

TRIAL REGISTRATION

The Chinese Clinical Trial Registry ( http://www.chictr.org.cn ) ChiCTR1900022583. Registered on 17 April 2019.

摘要

背景

谵妄是一种常见于接受心脏手术的患者的急性脑功能障碍，增加发病率和死亡率。它与风险因素有关，如年龄较大、使用麻醉剂、心肺旁路和低温。右美托咪定输注可能发挥神经保护作用。然而，围手术期给予右美托咪定对接受心脏或非心脏手术的患者术后谵妄（POD）的发生率的影响仍存在争议。本研究旨在揭示术中给予右美托咪定对心脏手术后成年患者谵妄发生率的影响。

方法

这项单中心、随机、双盲、安慰剂对照试验纳入了 652 名患者，随机分为两组：右美托咪定组和安慰剂组。右美托咪定组患者在中心静脉导管置入后 10 分钟内输注 0.6μg/kg 右美托咪定，然后以 0.4μg/kg/h 的速度持续输注至手术结束，而安慰剂组患者则以相同的速度输注生理盐水。主要结局是术后第 1 天至第 7 天期间 POD 的发生率。次要结局包括术后机械通气时间、术后入住重症监护病房和医院的时间、右美托咪定输注期间或之后低血压的发生率、术后住院期间急性肾损伤和突发性心律失常以及术后 30 天和 90 天的全因死亡率。