Actively Recruiting
Comparison of Remimazolam Alone, Propofol Alone, and Their Combination for Moderate Sedation During Endoscopic Examination and Treatment
Led by Kaohsiung Veterans General Hospital. · Updated on 2025-05-08
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are between 20 and 80 years old
- Anesthesiologists rated ASA as between I and III
- Patients undergoing upper gastrointestinal endoscopic examination or therapy
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the endoscopic procedure
Participants receive moderate sedation anesthesia using Remimazolam, Propofol, or their combination during upper gastrointestinal endoscopic examinations or treatments.
1 visit (in-person procedure day)
Duration - Up to 1 day post-procedure
Participants are monitored after sedation for recovery time, complications, pain intensity, nausea, and recall of surgery events.
1 to 2 visits including recovery room observation and ward follow-up
Trial Site Locations
Total: 1 location
1
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 81362
Actively Recruiting
Research Team
Y
Yuan-Yi Chia, M.D
C
Chen-Hsiu Chen, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Propofol sedation for ERCP procedures: a dilemna? Observations from an anesthesia perspective.
Davinder Garewal, Pallavi Waikar
https://pubmed.ncbi.nlm.nih.gov/22272061Anaesthetic considerations for endoscopic retrograde cholangio-pancreatography procedures.
Davinder Garewal, Liana Vele, Pallavi Waikar
https://pubmed.ncbi.nlm.nih.gov/23635608Remimazolam Dosing for Gastroscopy: A Randomized Noninferiority Trial.
Huichen Zhu, Zhongxue Su, Hongmei Zhou...
https://pubmed.ncbi.nlm.nih.gov/38039392Remimazolam versus propofol for sedation in gastrointestinal endoscopic procedures: a systematic review and meta-analysis.
Eduardo Cerchi Barbosa, Paula Arruda Espírito Santo, Stefano Baraldo...
https://pubmed.ncbi.nlm.nih.gov/38443286A randomized, controlled clinical trial comparing remimazolam to propofol when combined with alfentanil for sedation during ERCP procedures.
Shu-An Dong, Yan Guo, Sha-Sha Liu...
https://pubmed.ncbi.nlm.nih.gov/36764022Remimazolam versus propofol for sedation in gastrointestinal endoscopy and colonoscopy within elderly patients: a meta-analysis of randomized controlled trials.
Wania Ahmer, Sahar Imtiaz, Daniyal Muhammad Alam...
https://pubmed.ncbi.nlm.nih.gov/38261005A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy.
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https://pubmed.ncbi.nlm.nih.gov/30522856Intubation trauma and the head and neck surgeon: issues with a shared airway.
Jenny Montgomery, Louise Melia, Neil O'Donnell...
https://pubmed.ncbi.nlm.nih.gov/26609095