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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Time to Emergence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Remimazolam group
Patients will receive remimazolam for induction and maintenance of anesthesia.
Intervention: Remimazolam (Drug)
Remimazolam + Flumazenil group
Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.
Intervention: Remimazolam (Drug)
Remimazolam + Flumazenil group
Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.
Intervention: Flumazenil (Drug)
Propofol group
Patients will receive propofol for induction and maintenance of anesthesia.
Intervention: Propofol (Drug)
Outcomes
Primary Outcomes
Time to Emergence
Time Frame: 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 Outcomes
- Post-Operative Recovery(Within one day of surgery)
- Adverse Events(Within one day of surgery)
- Hemodynamic Parameters(During operation)
Investigators
Ru-Ping Dai
professor
Central South University