NCT06115031

Remimazolam vs. Propofol: Impact on Postoperative Delirium in Neurosurgical Patients

Effect of Remimazolam Versus Propofol Anesthesia on Postoperative Delirium in Neurosurgical Patients: A Randomised, Controlled, Noninferiority Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 696 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The investigator aimed to evaluate the incidence of postoperative delirium after remimazolam-based total intravenous anestheisa (TIVA) compared to the propofol-based TIVA in patients undergoing neurosurgery.

Detailed description

Remimazolam, a short-acting benzodiazepine, has recently gained approval for use in the induction and maintanance of general anesthesia. In American Society of Anesthesiologists (ASA) physical status class I and II patients undergoing general anesthesia, the remimazolam-based TIVA has shown comparable efficacy to propofol-based TIVA while demonstrating a superior safety profile. Remimazolam has exhibited a lower incidence of hypotension, reduced vasopressor requirements, and fewer instances of bradycardia compared to the propofol-based TIVA. The use of benzodiazepine has been associated with an increased risk of postoperative delirium, but there is currently no randomized controlled trial investigating the relationship between remimazolam, a new short-acting benzodiazepine, and postoperative delirium. Therefore, the investigators designed this prospective, randomized, double-blinded, active comparator-controlled, non-inferiority trial to investigate the incidence of postoperative delirium after remimazolam-based TIVA compared with propofol-based TIVA in neurosurgery patients.

Conditions

• Postoperative Delirium

Interventions

Type	Name	Description
DRUG	Remimazolam	General anesthesia will be induced and maintained using continuous infusion of intravenous remimazolam.
DRUG	Propofol	General anesthesia will be induced and maintained using target-controlled infusion of intravenous propofol.

Timeline

• Start date: 2024-01-29
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-11-02
• Last updated: 2024-04-17

Locations

1 site across 1 country: South Korea