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Clinical Trials/NCT06359834
NCT06359834
Recruiting
Not Applicable

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

Yonsei University1 site in 1 country112 target enrollmentApril 10, 2024

Overview

Phase
Not Applicable
Intervention
Remimazolam besylate
Conditions
Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography
Sponsor
Yonsei University
Enrollment
112
Locations
1
Primary Endpoint
Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2024
End Date
April 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Remimazolam

Patient group who receives remimazolam for sedation during endoscopy

Intervention: Remimazolam besylate

Propofol

Patient group who receives propofol for sedation during endoscopy

Intervention: Propofol

Outcomes

Primary Outcomes

Incidence of Oxygen Reserve Index (ORI) drop to 0.00 during sedation

Time Frame: 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.

Study Sites (1)

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