Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Last updated: May 6, 2025
Sponsor: Kaohsiung Veterans General Hospital.
Overall Status: Active - Recruiting

Phase

4

Condition

Constipation

Respiratory Failure

Lung Injury

Treatment

Propofol

Remimazolam

Clinical Study ID

NCT06777758
KSVGH24-CT8-16
  • Ages 20-80
  • All Genders

Study Summary

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects are between 20-80 years old.

  • Anesthesiologists rated ASA as between I and III.

  • Patients undergoing upper gastrointestinal endoscopic examination or therapy.

Exclusion

Exclusion Criteria:

  • Allergy to Propofol, Remimazolam, or opioid medications.

  • Emergency surgery.

  • Pregnancy.

  • History of malignant hyperthermia.

  • Impaired liver or kidney function.

  • Airway difficulties due to pharyngeal tumors.

  • Refusal to participate.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Propofol
Phase: 4
Study Start date:
February 12, 2025
Estimated Completion Date:
December 31, 2026

Study Description

Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

Connect with a study center

  • Kaohsiung Veterans General Hospital

    Kaohsiung, 81362
    Taiwan

    Active - Recruiting

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