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NCT Number: NCT06513923

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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

  1. Hemodynamic Parameters

    Time frame: During operation

    Blood pressure measured at various time points including diastolic and systolic blood pressure.

  2. Hemodynamic Parameters

    Time frame: During operation

    Heart rate measured at various time points.

  3. Post-Operative Recovery

    Time frame: 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.

  4. Adverse Events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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