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瑞马唑仑用于减少接受腹腔镜胃切除术的老年患者术后谵妄

2026年11月3日 更新者：Xiongxiong Pan、The First Affiliated Hospital with Nanjing Medical University

瑞马唑仑对老年腹腔镜胃癌根治术患者术后谵妄的影响：一项前瞻性随机对照试验

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded.

Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit.

The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.

研究类型

介入性

注册 (估计的)

170

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • 招聘中
        • The First Affiliated Hospital of Nanjing Medical University
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 100年 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥ 65 years.
  • Body mass index (BMI) between 18 and 28 kg/m².
  • ASA physical status I-III.
  • Scheduled for elective laparoscopic radical gastrectomy under general anesthesia at Jiangsu Province Hospital.
  • Able and willing to sign informed consent.

Exclusion Criteria:

  • Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
  • Stroke within the past 6 months or other central nervous system diseases.
  • History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis, or other psychiatric disorders.
  • History of alcohol abuse or psychoactive substance dependence.
  • Severe visual, hearing, or language impairment preventing communication.
  • Allergy or contraindication to propofol or benzodiazepines.
  • Preoperative cognitive impairment assessed by MMSE (≤24 for ≥middle-school education; ≤20 for primary school; ≤17 for no formal education).
  • Participation in another drug clinical trial within 1 month before surgery.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Remimazolam Group

Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
药品：Remimazolam

Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
有源比较器：Propofol Group

Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
药品：Propofol

Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
incidence of Postoperative Delirium
大体时间：From postoperative Day 1 to Day 3

Postoperative delirium will be assessed using the 3D-CAM diagnostic tool by trained evaluators blinded to group assignment. Delirium will be identified based on the presence of acute onset/fluctuation, inattention, altered consciousness, or disorganized thinking, following the standard 3D-CAM algorithm.
From postoperative Day 1 to Day 3

次要结果测量

结果测量
措施说明
大体时间
Emergence Agitation
大体时间：Immediately after extubation until PACU discharge

Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators.
Immediately after extubation until PACU discharge
Time to extubation
大体时间：At the end of surgery

Time from discontinuation of anesthetic agents to successful tracheal extubation.
At the end of surgery
Postoperative Pain Score
大体时间：At PACU discharge; postoperative day 1,day 2,and day 3.

Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10)
At PACU discharge; postoperative day 1,day 2,and day 3.
Post-induction Hypotension
大体时间：From completion of anesthetic induction to 10 minutes after induction.

Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to <65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction.
From completion of anesthetic induction to 10 minutes after induction.
Incidence of Postoperative Nausea and Vomiting
大体时间：From surgery until 48 hours postoperatively

Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period.
From surgery until 48 hours postoperatively
Length of Hospital Stay(days)
大体时间：From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)

Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system
From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The First Affiliated Hospital with Nanjing Medical University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月21日

初级完成 (估计的)

2026年12月25日

研究完成 (估计的)

2027年1月5日

研究注册日期

首次提交

2025年12月14日

首先提交符合 QC 标准的

2026年1月16日

首次发布 (实际的)

2026年1月20日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2025-SR-1025

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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