Trials / Recruiting
RecruitingNCT06777758
Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
The Comparison of Remimazolam or Propofol Used Alone Versus in Combination for Moderate Sedation During Endoscopic Examination and Treatment.
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Kaohsiung Veterans General Hospital. · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remimazolam | Remimazolam |
| DRUG | Propofol | Propofol dose reduction ratio |
Timeline
- Start date
- 2025-02-12
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2025-01-16
- Last updated
- 2025-05-08
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT06777758. Inclusion in this directory is not an endorsement.