Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments (Remimazolam)

May 6, 2025 updated by: Yuan-Yi Chia, Kaohsiung Veterans General Hospital.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol
The patient underwent a routine upper gastrointestinal endoscopy.
Drug: Propofol
Propofol dose reduction ratio
Experimental: Remimazolam
The patient underwent routine upper gastrointestinal endoscopy and Remimazolam was substituted for Propofol.
Drug: Remimazolam
Remimazolam
Experimental: Propofol + Remimazolam
The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.
Drug: Propofol
Propofol dose reduction ratio
Drug: Remimazolam
Remimazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose change
Time Frame: Perioperatively (during upper gastrointestinal endoscopy)
Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)
Perioperatively (during upper gastrointestinal endoscopy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After returning to the ward from the recovery room until before breakfast on the first postoperative day.
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.
The timer starts after the anesthetic is administered.
Use of rescue medications during surgery.
Time Frame: During surgery
Rescue drugs are used during the operation
During surgery
Analgesic dosage in the recovery room.
Time Frame: Observation period in the postoperative recovery room
Analgesic dosage in the postoperative recovery room.
Observation period in the postoperative recovery room
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.
The patients were followed up from the time they returned to the ward after surgery to the first day after surgery.
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.
Within 1 hour post-surgery.
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.
During the surgery (immediately after the first injection).
Recall of surgery events.
Time Frame: On postoperative day 1 (within 24 hours after surgery).
Recall events during surgery.
On postoperative day 1 (within 24 hours after surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Principal Investigator: CHIA-HAO YANG, M.D, employe
  • Principal Investigator: Tzung-Jim Tsai, M.D, employe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH24-CT8-16

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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