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

Phase 4

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography (ERCP); Endoscopic Ultrasound (EUS)
• Interventions: Drug: Meperidine, Midazolam; Drug: Diphenhydramine; Drug: Promethazine

• Registration Number: NCT00937924
• Lead Sponsor: University of California, Irvine

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2023-07-24
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-22
• Results First Posted: 2024-02-26
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meperidine and midazolam group	Meperidine, Midazolam	Control. Normal Saline Injections.
Meperidine and midazolam, plus Diphenhydramine group	Meperidine, Midazolam	Diphenhydramine injections given as adjunct sedative.
Meperidine and midazolam, plus Promethazne group	Meperidine, Midazolam	Promethazine given as an adjunct sedative.
Meperidine and midazolam, plus Diphenhydramine group	Diphenhydramine	Diphenhydramine injections given as adjunct sedative.
Meperidine and midazolam, plus Promethazne group	Promethazine	Promethazine given as an adjunct sedative.

Primary Outcome Measures

Name	Time	Method
Average Percentage of Sedation Failures	From onset of sedation to completion of procedure, approximately 1 hour.	The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Time to Achieve Adequate Level of Sedation to Begin Procedure	Pre-Endoscopic Procedure (up to 1 hour maximum)
Time for Recovery	Post-Endoscopic Procedure

Secondary Outcome Measures

Name	Time	Method
Adverse Symptoms From Sedative Agents	Approximately 3 hours.

Trial Locations

Locations (1)

H.H. Chao Comprehensive Digestive Disease Center; 🇺🇸 Orange, California, United States