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

Central South University

Status and phase: Completed; Phase 4

Conditions: Hip Fracture

Treatments: Drug: Flumazenil; Drug: Remimazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06513923

LYG2023002

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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136 participants in 3 patient groups

Remimazolam group

Experimental group

Description:

Patients will receive remimazolam for induction and maintenance of anesthesia.

Treatment:

Drug: Remimazolam

Remimazolam + Flumazenil group

Experimental group

Description:

Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.

Treatment:

Drug: Remimazolam

Drug: Flumazenil

Propofol group

Experimental group

Description:

Patients will receive propofol for induction and maintenance of anesthesia.

Treatment:

Drug: Propofol