Phase 4 N=304 Randomized Triple-blind Supportive Care

Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures

Endoscopic Ultrasound (EUS) · Endoscopic Retrograde Cholangiopancreatography (ERCP)

Bottom Line

View on ClinicalTrials.gov: NCT00937924 ↗

Enrolled (actual)

304

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Average Percentage of Sedation Failures — 14; 13; 5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Meperidine, Midazolam (Drug); Diphenhydramine (Drug); Promethazine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Percentage of Sedation Failures	14; 13; 5	—
PRIMARY Time to Achieve Adequate Level of Sedation to Begin Procedure	15; 13; 14	—
PRIMARY Time for Recovery	21.3; 29.5; 51.5	—
SECONDARY Adverse Symptoms From Sedative Agents	0; 0; 0	—

Summary

The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.

Eligibility Criteria

Inclusion Criteria

Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.

Exclusion Criteria

History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
Patients with conditions that preclude safe conscious sedation will be excluded.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00937924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.