Comparison of Remimazolam and Propofol Effect on Oxygen Reserve During Endoscopic Retrograde Cholangiopancreatography

Not Applicable

Recruiting

• Conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography
• Interventions: Drug: Remimazolam besylate; Drug: Propofol

• Registration Number: NCT06359834
• Lead Sponsor: Yonsei University

Brief Summary

Propofol is one of the most commonly used sedative in endoscopic procedures, while its potency to induce respiratory depression may threaten patient safety. Remimazolam is known to less likely induce hemodynamic instability when compared to propofol, yet its favorable effects are not clearly evaluated in endoscopic procedures. Hence, this study aimed to compare hemodynamic effects of remimazolam and propofol, by evaluating oxygen reserve index (ORI) in patients scheduled for endoscopic retrograde cholangiopancreatography.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-07
• Study First Submitted QC: 2024-04-07
• Last Update Submitted: 2024-04-07
• Study Start: 2024-04-10
• Study First Posted: 2024-04-11
• Last Update Posted: 2024-04-11
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Patients (age 19~80 yrs, ASA Class I~III) who are scheduled for elective endoscopic retrograde cholangiopancreatograph

Exclusion Criteria

• Pregnancy Allergy to remimazolam or propofol Underlying pulmonary diseases or obstructive sleep apnea Underlying renal (serum Cr >2mg/dL) or cardiac disease (NYHA class III or IV) Hypotension (SBP <90mmHg) or hypoxemia (SpO2 <90%) assessed prior to procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remimazolam	Remimazolam besylate	Patient group who receives remimazolam for sedation during endoscopy
Propofol	Propofol	Patient group who receives propofol for sedation during endoscopy

Primary Outcome Measures

Name	Time	Method
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation	Evaluation begins after sedative administration until the end of endoscopic procedure.	Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of