Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Phase 4

Recruiting

• Conditions: Postoperative Complications; Respiratory Depression; Postoperative Nausea; Vomiting; Constipation
• Interventions: Drug: Propofol; Drug: Remimazolam

• Registration Number: NCT06777758
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief 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.

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 Timeline

• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2025-01-15
• Study First Posted: 2025-01-16
• Study Start: 2025-02-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	The patient underwent a routine upper gastrointestinal endoscopy.
Remimazolam	Remimazolam	The patient underwent routine upper gastrointestinal endoscopy and Remimazolam was substituted for Propofol.
Propofol + Remimazolam	Remimazolam	The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.
Propofol + Remimazolam	Propofol	The patient underwent routine upper gastrointestinal endoscopy, and the anesthetic drug used was Propofol combined with Remimazolam.

Primary Outcome Measures

Name	Time	Method
Dose change	Perioperatively (during upper gastrointestinal endoscopy)	Change in Propofol dose ratio. (Record total dose, Duration, mg/h/kg)

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting.	After returning to the ward from the recovery room until before breakfast on the first postoperative day.	Track postoperative nausea and vomiting episodes.
Time to open eyes after stopping Propofol or Remimazolam.	The timer starts after the anesthetic is administered.	Eye open minutes after Propofol or Remimazolam stop.
Use of rescue medications during surgery.	During surgery	Rescue drugs are used during the operation
Analgesic dosage in the recovery room.	Observation period in the postoperative recovery room	Analgesic dosage in the postoperative recovery room.
Analgesic dosage in the ward.	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.
Pain Intensity (Visual Analog Scale, VAS) every 15 minutes in the recovery room for 1 hour after surgery.	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.
Pain from the first injection of medication.	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.
Recall of surgery events.	On postoperative day 1 (within 24 hours after surgery).	Recall events during surgery.

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan