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NCT Number: NCT06777758

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

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.

Recruiting

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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 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.

Treatment and study plan

Remimazolam

Drug

Remimazolam

Propofol

Drug

Propofol dose reduction ratio

Primary outcomes

  1. Dose change

    Time frame: Perioperatively (during upper gastrointestinal endoscopy)

    Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)

Secondary outcomes

  1. Incidence of postoperative nausea and vomiting.

    Time frame: After returning to the ward from the recovery room until before breakfast on the first postoperative day.

    Track postoperative nausea and vomiting episodes.

  2. Time to open eyes after stopping Propofol or Remimazolam.

    Time frame: The timer starts after the anesthetic is administered.

    Eye open minutes after Propofol or Remimazolam stop.

  3. Use of rescue medications during surgery.

    Time frame: During surgery

    Rescue drugs are used during the operation

  4. Analgesic dosage in the recovery room.

    Time frame: Observation period in the postoperative recovery room

    Analgesic dosage in the postoperative recovery room.

  5. Analgesic dosage in the ward.

    Time frame: The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.

    The dosage of analgesics used in post-operative wards.

  6. Pain Intensity (Visual Analog Scale, VAS) every 15 minutes in the recovery room for 1 hour after surgery.

    Time frame: Within 1 hour post-surgery.

    Assessment of pain intensity using the Visual Analog Scale (VAS), where 0 represents no pain and 10 represents the worst possible pain.

  7. Pain from the first injection of medication.

    Time frame: During the surgery (immediately after the first injection).

    Assessment of pain intensity caused by the first injection of medication, measured using the Visual Analog Scale (VAS) from 0 to 10.

  8. Recall of surgery events.

    Time frame: On postoperative day 1 (within 24 hours after surgery).

    Recall events during surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen-Hsiu Chen, Ph.D

CONTACT

[email protected]

886-7-342-2121 ext. 74105

Yuan-Yi Chia, M.D

CONTACT

[email protected]

886-7-342-2121 ext. 74105

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.

Acronym: Remimazolam

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2025
Registry last updated
May 8, 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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