Skip to main content
OpenTrials
Completed

NCT Number: NCT00937924

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP)

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

H.H. Chao Comprehensive Digestive Disease Center

Orange, California, 92868, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Meperidine, Midazolam

Drug

diphenhydramine

Drug

Promethazine

Drug

Primary outcomes

  1. 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

  2. Time to Achieve Adequate Level of Sedation to Begin Procedure

    Time frame: Pre-Endoscopic Procedure (up to 1 hour maximum)

  3. Time for Recovery

    Time frame: Post-Endoscopic Procedure

Secondary outcomes

  1. Adverse Symptoms From Sedative Agents

    Time frame: Approximately 3 hours.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 13, 2009
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.