Remimazolam-based anesthesia to reduce delirium after laparoscopic gastrectomy in older adults
Official title: Effect of Remimazolam on Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Radical Gastrectomy: A Prospective Randomized Controlled Trial
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07351474 · Data updated 2026-11-12
This study tests whether using remimazolam instead of propofol-based anesthesia lowers delirium after surgery in patients 65 and older undergoing laparoscopic gastrectomy for gastric cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years to 100 Years |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | January 21, 2026 |
| Main results expected | December 25, 2026 |
| Study ends | January 5, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07351474 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 65 or older, BMI 18–28 kg/m2, ASA I–III, scheduled for elective laparoscopic radical gastrectomy for gastric cancer at Jiangsu Province Hospital, who can consent.
✕Probably not a fit
Patients with severe organ dysfunction, certain CNS or psychiatric conditions, preoperative cognitive impairment beyond specified thresholds, or contraindications to propofol or benzodiazepines may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, participant- and outcome-blinded trial comparing remimazolam-based anesthesia with propofol-midazolam-based anesthesia in elderly adults undergoing elective laparoscopic radical gastrectomy for gastric cancer. All participants receive standardized perioperative care with BIS-guided depth control and postoperative analgesia; delirium is assessed daily on postoperative days 1–3 using validated tools. Primary outcome is the cumulative incidence of postoperative delirium in the first three days; secondary outcomes include peri-induction blood pressure changes, hemodynamic variables, recovery metrics, pain scores, and adverse events. The trial randomized 147 participants 1:1, with allocation concealed and outcome assessors blinded to treatment. The study ran at The First Affiliated Hospital of Nanjing Medical University between January and August 2026.
Why it matters
Potential benefit: If successful, remimazolam-based anesthesia could reduce postoperative delirium and improve perioperative stability for older gastric cancer patients.
How similar studies have gone: Previous similar approaches have shown potential in reducing delirium with remimazolam, but this trial provides targeted evidence in elderly gastrectomy patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Xiongxiong Pan
- Email: xiongxiong@njmu.edu.cn
- Phone: +86 13813801858
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.