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

NCT06359834 | Completed DMC

• 1 other identifier: 4-2023-1693
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatobiiliary Diseases Requiring Endoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

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

  Incidence of Oxygen Reserve Index (ORI) drop to 0.00 will be evaluated after sedative administration, until the end of endoscopic procedure.

  Evaluation begins after sedative administration until the end of endoscopic procedure.

Study Arms (2)

Remimazolam

EXPERIMENTAL

Patient group who receives remimazolam for sedation during endoscopy

Drug: Remimazolam besylate

Propofol

ACTIVE COMPARATOR

Patient group who receives propofol for sedation during endoscopy

Drug: Propofol

Interventions

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.

Remimazolam

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.

Propofol

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Kim JH, Lee K, Lee SJ, Leem G, Lee HS, Park JY, Bang S, Park SW, Kim N, Chung MJ. Remimazolam Preserves Oxygen Reserve and Improves Sedation Safety Compared to Propofol in Endoscopic Retrograde Cholangiopancreatography. United European Gastroenterol J. 2025 Nov;13(9):1730-1739. doi: 10.1002/ueg2.70105. Epub 2025 Sep 5.

  PMID: 40911638 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 11, 2024
• Study Start: April 11, 2024
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)