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ID06777758

Study Comparing Remimazolam Alone, Propofol Alone, and Their Combination for Moderate Sedation During Upper Gastrointestinal Endoscopy and Treatment

Led by Kaohsiung Veterans General Hospital. · Updated on 2025-05-08

90

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of Remimazolam, used alone or combined with Propofol, for moderate sedation anesthesia during endoscopic procedures such as upper gastrointestinal endoscopy. The study aims to determine if combining these drugs improves anesthesia quality and recovery outcomes compared to using each drug alone. This is a prospective, randomized study conducted at a single center, focusing on sedation during endoscopic examinations and treatments. Participants will be randomly assigned to one of three groups Propofol alone, Remimazolam alone, or a combination of both drugs for sedation during the procedure. Throughout the endoscopic examination, various measures will be recorded including anesthesia depth, heart rate, blood pressure, and oxygen levels. Researchers will also monitor recovery time, consciousness return, episodes of oxygen desaturation, patient movement, recall of the procedure, satisfaction of both patients and surgeons, readmission rates within 14 days, complications, and hospital stay length. During the study, participants will undergo routine upper gastrointestinal endoscopy with their assigned sedation method. Assessments will include monitoring vital signs, anesthesia depth, and collecting data on postoperative nausea, vomiting, pain intensity, and analgesic use. Pain will be evaluated using a visual scale every 15 minutes for one hour after surgery. The main outcome measured is the dose changes of sedative drugs during the procedure. Safety and recovery will be closely observed, with follow-up until the first day after surgery.

CONDITIONS

Brief Title

Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

Research Team

Y

Yuan-Yi Chia, M.D

C

Chen-Hsiu Chen, Ph.D

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