NCT07351474Recruiting
Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy
Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- First submitted
- 14 Dec 2025
- Start date
- 21 Jan 2026
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07351474
What you commit to
- Study type: Interventional
- Planned participants: 170
- From 21 Jan 2026 to the primary completion date, 25 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another drug clinical trial within 1 month before surgery.
Other illness
- 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).
Other
- Severe respiratory, cardiovascular, renal, or hepatic dysfunction.
Who the study is looking for
- 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.
Age in the registry: 65 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.