亚麻醉剂量艾司氯胺酮预防老年心血管手术患者术后谵妄的疗效：中国一项单中心、随机、双盲、安慰剂对照试验（SEPDOC试验）的方案

Efficacy of subanaesthetic esketamine on the prevention of postoperative delirium in older adult patients after cardiovascular surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial (SEPDOC trial) in China.

作者信息

Yan Ju-Min, Liu Qing-Ren, Zhao Liang, Yang Jian-Jun, Lin Hong-Qi, Wen Zhao-Yu, Zhang Hao-Ran, Mei Yi-Xin, Zhang Wei, Wang Rui-Di

机构信息

Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.

Department of Anesthesiology and Perioperative Medicine, Central China Branch of National Center for Cardiovascular Diseases, Henan Cardiovascular Disease Center, Fuwai Central-China Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Province Clinical Research Center for Cardiovascular Disease, Zhengzhou, Henan, China.

出版信息

BMJ Open. 2025 Jun 16;15(6):e089719. doi: 10.1136/bmjopen-2024-089719.

DOI:10.1136/bmjopen-2024-089719

PMID:40523785

Abstract

INTRODUCTION

Postoperative delirium (POD) is a common and serious complication in older adult patients undergoing cardiovascular surgery. Esketamine is known for its anti-inflammatory and neuroprotective properties. While it has shown preventive effects on POD in those not undergoing cardiovascular surgery, its efficacy in older adult patients undergoing cardiovascular surgery remains uncertain. Therefore, we herein aimed to evaluate the preventive effect of intraoperative subanaesthetic esketamine on POD in this specific population.

METHODS AND ANALYSIS

This single-centre, randomised, double-blind, placebo-controlled trial will enrol 778 patients aged 60-80 years undergoing open-heart cardiovascular surgery in China, from September 2023 to December 2025. The participants will be randomly assigned in a 1:1 ratio to the following groups: the esketamine group and the control group. In the esketamine group, esketamine (2 mg/mL) will be administered intravenously at a dosage of 0.3 mg/kg over 10 min following tracheal intubation, followed by a continuous infusion at 0.15 mg/kg/h until the end of the surgery. Patients in the control group will receive a placebo following the same dosage and regimen. The incidence of POD will be the primary outcome and will be assessed twice daily from the first to the seventh postoperative day. The postoperative sleep quality, duration of postoperative mechanical ventilation, and length of hospital and intensive care unit stay will be the secondary outcomes.

ETHICS AND DISSEMINATION

Ethical approval was obtained from the Institutional Review Board of Fuwai Central China Cardiovascular Hospital (No. 2023068). Public disclosure is guaranteed post-trial, and the results will be published in a peer-reviewed scientific journal.

TRIAL REGISTRATION NUMBER

ChiCTR2300074395.

摘要

引言

术后谵妄（POD）是老年心血管手术患者常见且严重的并发症。艾司氯胺酮以其抗炎和神经保护特性而闻名。虽然它已显示出对非心血管手术患者的POD有预防作用，但其在老年心血管手术患者中的疗效仍不确定。因此，我们在此旨在评估术中亚麻醉剂量艾司氯胺酮对该特定人群POD的预防效果。

方法与分析

本单中心、随机、双盲、安慰剂对照试验将于2023年9月至2025年12月在中国招募778名年龄在60 - 80岁接受心脏直视心血管手术的患者。参与者将按1:1比例随机分配到以下组：艾司氯胺酮组和对照组。在艾司氯胺酮组中，气管插管后10分钟内静脉注射艾司氯胺酮（2mg/mL），剂量为0.3mg/kg，随后以0.15mg/kg/h持续输注直至手术结束。对照组患者将按照相同剂量和方案接受安慰剂。POD的发生率将作为主要结局，术后第1天至第7天每天评估两次。术后睡眠质量、术后机械通气时间、住院时间和重症监护病房停留时间将作为次要结局。