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Completed

NCT Number: NCT05651399

Comparison in Frequency of Hypotension Between Remimazolam and Propofol in Hip Surgery

The purpose of this study is to compare the incidence of hypotension between remimazolam and propofol for intraoperative sedation in patients undergoing hip surgery with spinal anesthesia.

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Key information

Conditions

Remimazolam Anesthesia, Spinal Orthopedic Procedures Propofol Sedatives

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center

Seoul, 05505, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA physical status 1-3
  • Patients scheduled for hip joint surgery under spinal anesthesia and sedation with propofol or remimzolam

Exclusion criteria

  • Patients who refuse to participate in this study
  • Patients with uncontrolled high blood pressure, hyperthyroidism, dementia in the inability to communicate, or symptomatic coronary artery disease
  • Patients with an allergy to propofol, fentanyl, or bupivacaine
  • Patients contraindicated for spinal anesthesia, such as coagulopathy, severe aortic stenosis/mitral stenosis, and active infection on lumbar region
  • Patients judged to be inappropriate for this study

Treatment and study plan

Remimazolam

Drug

Patients receive remimazolam at a rate of 1 mg/kg/hr. When a patient's MOAA/S reaches 3 or less, the rate of remomazolam is maintained at a rate between 0.3 mg/kr/hr and 1.0 mg/kg/hr until the end of surgery.

Propofol

Drug

Patients are administered propofol with an effect-site concentration of 1.0 mcg/mL to 2.5 mcg/mL by target controlled infusion.

Primary outcomes

  1. Frequency of hypotension during surgery (1hour)

    Time frame: up to 1 hour after initiation of drug infusion

    mean blood pressure less than 65mmHg

Secondary outcomes

  1. Frequency of hypotension during surgery

    Time frame: Throughout the surgery

    mean blood pressure less than 65mmHg

  2. Total administered phenylephrine

    Time frame: Throughout the surgery

    total dose of phenylephrine administered during surgery

  3. Fluid volume

    Time frame: Throughout the surgery

    Total amount of fluid infused during surgery

  4. Number of hypotensive episodes in the post-anesthesia care unit after surgery

    Time frame: up to 1 hour after postanesthesia care unit entry

    mean blood pressure less than 65mmHg

  5. Complications after surgery

    Time frame: up to 7 days after surgery

    Cardiovascular/neurological/respiratory complications, delirium, impaired renal function, or postoperative nausea and vomiting

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

Comparison in Frequency of Hypotension During Sedation of Propofol and Remimazolam in Spinal Anesthesia in Hip Surgery Patients: a Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2022
Registry last updated
Feb 26, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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