A Non-Inferiority Study of Remimazolam versus Propofol in ERCP

Not Applicable

Completed

• Conditions: Diseases of the digestive system

• Registration Number: KCT0008459
• Lead Sponsor: Inha University Hospital

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) requires an ideal sedative that provides a predictable action duration and meets safety requirements. We compared the efficacies and safeties of remimazolam and propofol in patients who had undergone ERCP. In this prospective, randomized, double-blind, single-center study, we compared the performances of remimazolam and propofol for inpatient ERCP. Study medications were administered under the supervision of an endoscopist. One hundred and ten patients scheduled to undergo ERCP were randomly assigned to receive remimazolam or propofol. The primary endpoint was a composite of successful completion of the procedure and no requirement for rescue medication. Secondary endpoints included sedation efficacy, recovery time, and adverse events. Of the 110 patients randomized, 108 underwent sedation and ERCP (53 received remimazolam and 55 propofol). The primary endpoint was met for remimazolam and propofol in 100% of patients in both arms. Incidences and frequencies of emergent adverse events, including desaturation, requiring treatment were comparable in both arms. However, ERCP was started sooner in the propofol arm (mean, 63.18 ± 16.56 sec) than in the remimazolam arm (75.23 ± 32.27 sec; p-value=0.02). Time to full alertness after ERCP was also significantly shorter in the propofol arm (304.18 ± 146.25 vs. 448.34 ± 224.09 sec; p-value<0.001). Remimazolam is not inferior to propofol in achieving successful ERCP completion without rescue medication. Incidences of adverse events were comparable. Remimazolam is a safe and effective alternative to propofol for ERCP sedation, expanding options for clinicians and improving patient outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-09
• Last Update Posted: 30 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

(1) > 19 years old, (2) scheduled for a diagnostic or therapeutic ERCP, (3) patients who have provided informed consent for voluntary participation in research

Exclusion Criteria

(1) Patients incapable of endoscopic retrograde cholangiopancreatography
(2) Patients who did not agree to participate in the study
(3) Patients unable to administer Remimazolam or propofol

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint was a composite of successful completion of the procedure and no requirement for rescue medication.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints included sedation efficacy, recovery time, and adverse events.