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

NCT06513923 | Completed Phase 4

• 1 other identifier: LYG2023002
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Time to Emergence

  Defined as the time from discontinuation of the anesthetic agent to the time the patient opens their eyes on verbal command.

  Within one day of surgery

Secondary Outcomes (4)

• Hemodynamic Parameters

  During operation

• Hemodynamic Parameters

  During operation

• Post-Operative Recovery

  Within one day of surgery

• Adverse Events

  Within one day of surgery

Study Arms (3)

Remimazolam group

EXPERIMENTAL

Patients will receive remimazolam for induction and maintenance of anesthesia.

Drug: Remimazolam

Remimazolam + Flumazenil group

EXPERIMENTAL

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

Drug: Remimazolam; Drug: Flumazenil

Propofol group

EXPERIMENTAL

Patients will receive propofol for induction and maintenance of anesthesia.

Drug: Propofol

Interventions

Remimazolam DRUG

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.

Remimazolam + Flumazenil group; Remimazolam group

Flumazenil DRUG

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.

Remimazolam + Flumazenil group

Propofol DRUG

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.

Propofol group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (2)

Department of Anesthesiology, The Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

The Second Xiangya Hospital

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

remimazolam; Flumazenil; Propofol

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ru-Ping MD Dai, PhD

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 22, 2024
• Study Start: February 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

CN (2)