NCT06513923

Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia

Comparative Study of Remimazolam, Remimazolam Plus Flumazenil vs Propofol Anesthesia on Emergence Time in Elderly Patients Undergoing Hip Replacement: A Randomized, Double Blinded Controlled Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Central South University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Purpose: This study aims to compare the emergence time among three anesthesia regimens: remimazolam, remimazolam with flumazenil, and propofol in elderly patients undergoing hip replacement surgery. Background: Previous studies have shown that flumazenil accelerates emergence time when used with remimazolam. Remimazolam and propofol have comparable emergence times, although remimazolam can be up to 5 minutes longer than propofol.

Conditions

• Hip Fracture

Interventions

Type	Name	Description
DRUG	Remimazolam	In Remimazolam group, the induction dose of remimazolam is 0.3 mg/kg based on previous studies, the maintenance of anesthesia is 0.3-0.7 mg/kg/hr.
DRUG	Flumazenil	Immediately after the cessation of remimazolam infusion in PACU(PACU, Postanesthesia care unit), the nurses who are blind to the anesthesia management were asked to administer the flumazenil.
DRUG	Propofol	For propofol group, the induction of propofol is 1.5-2.0 mg/kg, followed by the maintenance of propofol infusion with 6-8 mg/kg/hr throughout the surgical procedure.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-09-30
• Completion: 2023-10-31
• First posted: 2024-07-22
• Last updated: 2024-07-24

Locations

2 sites across 1 country: China