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

Phase 4

Completed

• Conditions: Hip Fracture
• Interventions: Drug: Propofol; Drug: Remimazolam; Drug: Flumazenil

• Registration Number: NCT06513923
• Lead Sponsor: Central South University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-10-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-05
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Elderly patients (≥65 years old).
• Scheduled for elective hip replacement surgery.
• ASA (ASA, American Society of Anesthesiologists) physical status I-III.
• Able to provide informed consent.

Exclusion Criteria

• Known hypersensitivity to remimazolam, flumazenil, or propofol.
• Severe hepatic or renal impairment.
• History of benzodiazepine or alcohol abuse.
• Cognitive impairment that may interfere with the ability to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam + Flumazenil group	Flumazenil	Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.
Propofol group	Propofol	Patients will receive propofol for induction and maintenance of anesthesia.
Remimazolam group	Remimazolam	Patients will receive remimazolam for induction and maintenance of anesthesia.
Remimazolam + Flumazenil group	Remimazolam	Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.

Primary Outcome Measures

Name	Time	Method
Time to Emergence	Within one day of surgery	Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command.

Secondary Outcome Measures

Name	Time	Method
Post-Operative Recovery	Within one day of surgery	Assessed using the Modified Aldrete Score.The modified Aldrete score is measured by evaluating five criteria, including the individual's activity level, respiration, circulation, consciousness, and oxygen saturation. A score of "0", "1", or "2" is given for each category, two representing the ideal condition.Given the five parameters, individuals can have a total score from zero to ten. A score lower than nine typically means the individual's status is suboptimal.
Adverse Events	Within one day of surgery	Incidence and severity of adverse events related to anesthesia(injection pain, post-induction hypotension, bradycardia and body movement, postoperative nausea and vomiting, intraoperative awareness and delirium, sedation rescue and re-sedation).
Hemodynamic Parameters	During operation	Heart rate measured at various time points.

Trial Locations

Locations (2)

Department of Anesthesiology, The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China

The Second Xiangya Hospital; 🇨🇳 Changsha, Hunan, China