Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Starting soon · Not applicable
Conditions studied: Gastric Cancer, Postoperative Delirium
In brief
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.
Key facts
- Study ID
- NCT07351474
- Run by
- The First Affiliated Hospital with Nanjing Medical University
- People needed
- 170
- Starts
- 2026-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-20
Who can join
Age: 65 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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