Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

January 16, 2026 updated by: Xiongxiong Pan, The First Affiliated Hospital with Nanjing Medical University

Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial

This prospective, randomized controlled clinical trial aims to evaluate whether remimazolam can reduce the incidence of postoperative delirium (POD) in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer. A total of 170 patients aged 65 years or older will be enrolled and randomized in a 1:1 ratio to receive either remimazolam or a propofol-midazolam regimen for anesthesia induction and maintenance. Standard perioperative monitoring, BIS-guided anesthesia depth control, and postoperative pain management will be applied in both groups. The primary outcome is the incidence of postoperative delirium within 5 days after surgery, assessed twice daily using the 3D-CAM. Secondary outcomes include emergence agitation, extubation time, postoperative pain scores, cognitive function at discharge, intraoperative hemodynamic stability, unplanned ICU admission, postoperative complications, and length of ICU stay. This study aims to determine whether remimazolam provides a safer and more effective anesthetic option for improving postoperative neurological outcomes and recovery in elderly patients undergoing laparoscopic radical gastrectomy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, controlled clinical trial is designed to investigate the efficacy and safety of remimazolam in reducing postoperative delirium (POD) among elderly patients undergoing laparoscopic radical gastrectomy. Postoperative delirium is a common and serious complication in older surgical patients and is associated with prolonged recovery, cognitive decline, increased morbidity, higher healthcare costs, and long-term mortality. Despite advances in perioperative care, effective strategies for reducing POD in elderly patients undergoing major abdominal surgery remain limited. Remimazolam, a novel ultra-short-acting benzodiazepine, offers rapid metabolism, hemodynamic stability, and reliable reversibility, making it a potentially advantageous anesthetic agent for this high-risk patient population.

A total of 170 eligible patients aged 65 years or older will be enrolled at The First Affiliated Hospital of Nanjing Medical University. Participants will be randomized in a 1:1 ratio to receive either remimazolam (R group) or a propofol-midazolam regimen (P group) during anesthesia induction and maintenance. Randomization will be performed using a computer-generated sequence and sealed opaque envelopes. Anesthesia depth will be monitored by BIS, and drug dosages will be dynamically adjusted to maintain BIS between 40 and 60 while keeping hemodynamic parameters within 20% of baseline values. Standardized perioperative management will be applied to all participants, including opioid analgesia, muscle relaxation, controlled ventilation, vasoactive medication titration, and postoperative PCIA.

Postoperative delirium will be assessed twice daily from postoperative day 1 to day 5 using the 3D-CAM diagnostic criteria by trained evaluators blinded to group allocation. Delirium assessments will also be conducted on the day of surgery at least two hours after emergence. Additional postoperative evaluations will include pain scores (NRS), emergence agitation, MMSE cognitive assessments, extubation time, PACU duration, length of hospitalization, and adverse events such as intraoperative awareness, hypotension, postoperative nausea and vomiting, or unplanned ICU admission.

Intraoperative data-including anesthesia duration, surgical duration, anesthetic drug dosages, opioid consumption, vasoactive medication use (converted to norepinephrine-equivalent doses), fluid balance, and estimated blood loss-will be recorded. Preoperative data collection includes demographics, comorbidities, Charlson Comorbidity Index, medication history, laboratory findings, and sleep quality. Data collection will continue until postoperative day 5 or hospital discharge, whichever occurs first.

The primary outcome of this trial is the incidence of postoperative delirium within five days after surgery. Secondary outcomes include the severity and subtype of delirium, emergence agitation, cognitive function at discharge, postoperative pain scores, extubation time, postoperative complications, PACU stay, ICU stay, and length of hospitalization. Statistical analyses will be conducted by investigators blinded to group allocation using standard tests for normality, t-tests or Mann-Whitney U tests for continuous variables, and Chi-square or Fisher exact tests for categorical variables. A two-sided P value <0.05 will be considered statistically significant.

This study is expected to provide evidence regarding whether remimazolam offers superior neurocognitive outcomes, improved hemodynamic stability, and fewer postoperative complications compared with propofol-based anesthesia in elderly patients undergoing laparoscopic radical gastrectomy. The findings may support the development of safer anesthesia strategies and enhanced recovery protocols for elderly surgical patients.

Study Type

Interventional

Enrollment (Estimated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remimazolam Group
Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
Drug: 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.
Active Comparator: Propofol Group
Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of Postoperative Delirium
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergence Agitation
Time Frame: 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
Time Frame: At the end of surgery
Time from discontinuation of anesthetic agents to successful tracheal extubation.
At the end of surgery
Postoperative Pain Score
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 14, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SR-1025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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