A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)

University of California, Irvine1 site in 1 country304 target enrollmentFebruary 2008

ConditionsEndoscopic Ultrasound (EUS)Endoscopic Retrograde Cholangiopancreatography (ERCP)

InterventionsMeperidine, Midazolam Diphenhydramine Promethazine

DrugsMeperidine, Midazolam Diphenhydramine Promethazine

Overview

Phase: Phase 4
Intervention: Meperidine, Midazolam
Conditions: Endoscopic Ultrasound (EUS)
Sponsor: University of California, Irvine
Enrollment: 304
Locations: 1
Primary Endpoint: Average Percentage of Sedation Failures
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

June 2012

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Irvine

Responsible Party

Principal Investigator

Kenneth J. Chang

Principal Investigator

University of California, Irvine

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.