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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2012

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.

Interventions

  • Drug: Meperidine, Midazolam
  • Drug: Diphenhydramine
  • Drug: Promethazine

Arms, Groups and Cohorts

  • Placebo Comparator: Meperidine and midazolam group
    • Control. Normal Saline Injections.
  • Experimental: Meperidine and midazolam, plus Diphenhydramine group
    • Diphenhydramine injections given as adjunct sedative.
  • Experimental: Meperidine and midazolam, plus Promethazne group
    • Promethazine given as an adjunct sedative.

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Time to Achieve Adequate Level of Sedation to Begin Procedure
    • Time Frame: Pre-Endoscopic Procedure (up to 1 hour maximum)
  • Time for Recovery
    • Time Frame: Post-Endoscopic Procedure

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, Irvine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kenneth J. Chang, Principal Investigator – University of California, Irvine
  • Overall Official(s)
    • Kenneth Chang, MD, Principal Investigator, UC Irvine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.