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.
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.
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.
Parallel
Remimazolam
DrugRemimazolam will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
Propofol
DrugPropofol will be used as the primary anesthetic agent for induction and maintenance. Dosage will be adjusted to maintain BIS between 40 and 60.
incidence of Postoperative Delirium
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.
Emergence Agitation
Emergence agitation will be assessed in the PACU using the RASS or agitation scale by blinded evaluators.
Time to extubation
Time from discontinuation of anesthetic agents to successful tracheal extubation.
Postoperative Pain Score
Pain itensity will be evaluated using the Numerical Rating Scale(NRS,0-10)
Post-induction Hypotension
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.
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