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

February 22, 2024 updated by: Kenneth J. Chang, University of California, Irvine

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Venkataraman Muthusamy, MD
  • Phone Number: 714 456-5765
  • Email: raman@uci.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • H.H. Chao Comprehensive Digestive Disease Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Meperidine and midazolam group
Control. Normal Saline Injections.
Drug: Meperidine, Midazolam
Experimental: Meperidine and midazolam, plus Diphenhydramine group
Diphenhydramine injections given as adjunct sedative.
Drug: Diphenhydramine
Drug: Meperidine, Midazolam
Experimental: Meperidine and midazolam, plus Promethazne group
Promethazine given as an adjunct sedative.
Drug: Promethazine
Drug: Meperidine, Midazolam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time for Recovery
Time Frame: Post-Endoscopic Procedure
Post-Endoscopic Procedure
Average Percentage of Sedation Failures
Time Frame: 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
From onset of sedation to completion of procedure, approximately 1 hour.
Time to Achieve Adequate Level of Sedation to Begin Procedure
Time Frame: Pre-Endoscopic Procedure (up to 1 hour maximum)
Pre-Endoscopic Procedure (up to 1 hour maximum)

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse Symptoms From Sedative Agents
Time Frame: Approximately 3 hours.
Approximately 3 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

  • Principal Investigator: Kenneth Chang, MD, UC Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

June 4, 2008

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimated)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20075810

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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