Clinical trial · Interventional
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
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Postoperative Delirium | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Propofol | Drug | — | UNRESOLVED |
| Remimazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remimazolam Group
- description
- Participants in this group will receive remimazolam for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
- interventionNames
- Drug: Remimazolam
- type
- ACTIVE_COMPARATOR
- label
- Propofol Group
- description
- Participants in this group will receive propofol for anesthesia induction and maintenance during laparoscopic radical gastrectomy.
- interventionNames
- Drug: Propofol
Primary outcomes (1)
- measure
- incidence of Postoperative Delirium
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDBray 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