Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

NCT07351474 | Not Yet Recruiting

• 1 other identifier: 2025-SR-1025
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Gastric Cancer

Keywords

Remimazolam; Propofol; Elderly Patients; Laparoscopic Gastrectomy; Anesthesia; Postoperative Delirium

Outcome Measures

Primary Outcomes (1)

• incidence of Postoperative Delirium

  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 Outcomes (6)

• Emergence Agitation

  Immediately after extubation until PACU discharge

• Time to extubation

  At the end of surgery

• Postoperative Pain Score

  At PACU discharge; postoperative day 1,day 2,and day 3.

• Post-induction Hypotension

  From completion of anesthetic induction to 10 minutes after induction.

• Incidence of Postoperative Nausea and Vomiting

  From surgery until 48 hours postoperatively

Study Arms (2)

Remimazolam Group

EXPERIMENTAL

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

Drug: Remimazolam

Propofol Group

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Remimazolam DRUG

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

Remimazolam Group

Propofol DRUG

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

Propofol Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

  PMID: 38572751 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Emergence Delirium

Interventions

remimazolam; Propofol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Xiongxiong Pan

CONTACT

+86 13813801858; xiongxiong@njmu.edu.cn

Siyang Li

CONTACT

+86 18745228706; hilary37727@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)