Gastric Cancer, Postoperative Delirium
Conditions
Keywords
Remimazolam, Propofol, Elderly Patients, Laparoscopic Gastrectomy, Anesthesia, Postoperative Delirium
Brief summary
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.
Detailed description
This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial was conducted at the First Affiliated Hospital of Nanjing Medical University between January 21 and August 5, 2026. Patients aged 65 years or older who were scheduled to undergo elective laparoscopic radical gastrectomy for gastric cancer were screened for eligibility. A total of 147 participants were randomized in a 1:1 ratio to receive either remimazolam-based anesthesia or propofol-midazolam-based anesthesia. Randomization was based on a computer-generated sequence, with allocation concealed using sequentially numbered, opaque, sealed envelopes. Participants and postoperative outcome assessors were blinded to treatment allocation, whereas the attending anesthesiologists administering the allocated anesthetic regimen were not blinded. Standardized perioperative monitoring and management were applied in both groups, including bispectral index-guided anesthetic depth control, opioid analgesia, neuromuscular blockade, controlled ventilation, vasoactive medication titration, and postoperative patient-controlled intravenous analgesia. Postoperative delirium was assessed once daily between 14:00 and 17:00 on postoperative days 1-3. Ward patients were assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method, whereas patients admitted to the intensive care unit were assessed using the Confusion Assessment Method for the Intensive Care Unit. The original protocol specified standardized delirium assessment through postoperative day 5. Owing to limited research personnel during trial implementation, standardized assessments could only be consistently completed through postoperative day 3. Therefore, the primary outcome was the cumulative incidence of POD during postoperative days 1-3, and no assumptions were made regarding delirium status on postoperative days 4 and 5. Secondary outcomes included post-induction hypotension, maximum reduction in mean arterial pressure from baseline, peri-induction vasoactive drug requirements, peri-induction mean arterial pressure, heart rate and bispectral index trajectories, time to extubation, length of stay in the post-anesthesia care unit and hospital, postoperative pain scores, postoperative nausea and vomiting, PACU hypoxemia, emergence agitation, unplanned intensive care unit admission, and postoperative pulmonary infection.
Interventions
DRUGRemimazolam
Remimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
DRUGPropofol
Propofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of Postoperative Delirium | From postoperative Day 1 to Day 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergence Agitation | Immediately after extubation until PACU discharge | Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators. |
| Time to extubation | At the end of surgery | Time from discontinuation of anesthetic agents to successful tracheal extubation. |
| Postoperative Pain Score | At PACU discharge; postoperative day 1,day 2,and day 3. | Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10) |
| Post-induction Hypotension | From completion of anesthetic induction to 10 minutes after induction. | Post-induction hypotension will be defined as a decrease in mean arterial pressure (MAP) to \<65 mmHg or a reduction of ≥30% from baseline within the first 10 minutes after anesthetic induction. |
| Incidence of Postoperative Nausea and Vomiting | From surgery until 48 hours postoperatively | Postoperative nausea and vomiting assessed as the presence or absence based on patient reports and medical records during the postoperative period. |
| Length of Hospital Stay(days) | From the day of surgery (Day 0) to the date of hospital discharge (expected within 7-14 days postoperatively) | Length of hospital stay is defined as the number of calendar days from the date of surgery (Day 0) until the date of hospital discharge , as recorded in the electronic medical record system |
Countries
China
Outcome results
None listed