Efficacy and Safety of Remimazolam in Endoscopic Sedation-A Systematic Review and Meta-Analysis.
Xianlin Zhu, Hongbai Wang, Su Yuan...
https://pubmed.ncbi.nlm.nih.gov/34381792Actively Recruiting
Phase 4
Age: 18Years - 60Years
All Genders
ID07456111
Comparison of Remimazolam Besylate and Propofol Sedation During Colonoscopic Polypectomy Procedures
Led by Clinical Hospital Centre Zagreb · Updated on 2026-03-06
90
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is investigating sedation methods during colonoscopic polypectomy procedures. It aims to compare the effects of remimazolam besylate combined with sufentanyl versus propofol combined with sufentanyl on circulatory and respiratory stability. The study also evaluates the incidence of hypotension and respiratory depression, as well as the overall sedation success and recovery times in adult patients. Participants are randomly assigned to one of two groups: a study group receiving remimazolam besylate and sufentanyl, and a control group receiving propofol and sufentanyl. In both groups, patients receive intravenous sufentanyl followed by the sedative drug, with doses tailored to achieve the desired sedation level assessed by BIS monitoring and the Modified Observers Assessment of Alertness and Sedation Scale (MOAA/S). Continuous oxygen flow and non-invasive monitoring are applied during the procedure. Throughout the study, patients are monitored for vital signs including oxygen saturation, heart rate, blood pressure, and respiratory rate before, during, and after the procedure. Sedation depth, time to adequate sedation, full alertness, and recovery readiness are measured. Researchers also track drug doses, procedure duration, infusion volumes, and post-procedure symptoms such as pain, nausea, and vomiting. The total observation period per participant spans approximately 2 to 4 hours.
CONDITIONS
Brief Title
A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy
Who Can Participate
Age: 18Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients of any gender aged 18 to 60 years
- Confirmed diagnosis of one or more colonic polyps and scheduled for colonoscopy and polypectomy
- Colonoscopy duration expected between 30 and 50 minutes
- ASA physical status classification I to III
- Body Mass Index between 18.5 and 29.9 kg/m2
- Signed informed consent to participate in the study
You will not qualify if you...
- Age over 60 years
- ASA physical status classification IV or V
- Body Mass Index greater than 29.9 kg/m2
- High risk of vomiting, regurgitation, or aspiration of gastric contents
- Uncontrolled hypertension with systolic pressure over 160 mmHg
- Heart diseases including cardiomyopathy, rhythm disorders, low ejection fraction, valve issues, or coronary disease
- Lung diseases such as pneumonia, COPD, asthma, or pulmonary tumors
- Kidney failure or impaired kidney function (glomerular filtration rate 30-59 ml/min/1.73m2)
- Liver diseases
- Blood clotting or lymphatic tissue disorders
- Advanced malignant disease
- Allergies to soy, benzodiazepines, propofol, or opioids
- Current use of analgesics or psycho-pharmaceutical medications
- History of illicit drug use
- Children, pregnant or nursing women
- Alcohol dependency
- Participation in other clinical studies
- Refusal or failure to sign informed consent form
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 30 to 50 minutes
Participants receive sedation with either remimazolam besylate or propofol during their colonoscopic polypectomy procedure. Sedation is carefully monitored using BIS and MOAA/S scales, with continuous measurement of vital signs including oxygen saturation, respiratory rate, heart rate, and blood pressure to ensure safety and effectiveness.
1 procedure visit (in-person)
Follow-up
Duration - Up to 2 hours after the procedure
Participants are monitored after the procedure until full recovery, including assessment of time to full alertness and readiness for discharge based on recovery criteria.
1 to 2 post-procedure visits (in-person)
Trial Site Locations
Total: 1 location
1
UHC Zagreb
Zagreb, Croatia, 10000
Actively Recruiting
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Research Team
Ž
Željko Drvar, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Keith M Borkett, Dennis S Riff, Howard I Schwartz...
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Douglas K Rex, Raj Bhandari, Taddese Desta...
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https://pubmed.ncbi.nlm.nih.gov/35139608