Completed

NCT Number: NCT06359834

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

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.

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Key information

Conditions

Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remimazolam besylate

Drug

Patients in this group receives 0.1mg/kg of remimazolam to induce sedation prior to endoscope insertion. Remimazolam 2mg is added in case of inadequate sedation.

Propofol

Drug

Patients in this group receives 1mg/kg of propofol to induce sedation prior to endoscope insertion. Propofol 20mg is added in case of inadequate sedation.

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.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Apr 11, 2024
Registry last updated: Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.