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

Yonsei University

Status: Completed

Conditions: Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography

Treatments: Drug: Propofol; Drug: Remimazolam besylate

Study type: Interventional

Funder types: Other

Identifiers

NCT06359834

4-2023-1693

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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112 participants in 2 patient groups

Remimazolam

Experimental group

Description:

Patient group who receives remimazolam for sedation during endoscopy

Treatment:

Drug: Remimazolam besylate

Propofol

Active Comparator group

Description:

Patient group who receives propofol for sedation during endoscopy

Treatment:

Drug: Propofol