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

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 Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol; Drug: Flumazenil

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • Department of Anesthesiology, The Second Xiangya Hospital
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam group; Patients will receive remimazolam for induction and maintenance of anesthesia.	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.
Experimental: Remimazolam + Flumazenil group; Patients will receive remimazolam for induction and maintenance, followed by flumazenil to reverse its effects.	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.
Experimental: Propofol group; Patients will receive propofol for induction and maintenance of anesthesia.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemodynamic Parameters	Blood pressure measured at various time points including diastolic and systolic blood pressure.	During operation
Hemodynamic Parameters	Heart rate measured at various time points.	During operation
Post-Operative Recovery	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.	Within one day of surgery
Adverse Events	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).	Within one day of surgery

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Ru-Ping MD Dai, PhD, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 5, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Protective Agents; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Antidotes; Propofol; Flumazenil
• Other Study ID Numbers: LYG2023002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No