Orange, California 92868

  • Endoscopic Retrograde Cholangiopancreatography (ERCP)

Purpose:

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 summary:

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.


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.


NCT ID:

NCT00937924


Primary Contact:

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


Backup Contact:

Email: sbreddy@uci.edu
Swapna Reddy, MD


Location Contact:

Orange, California 92868
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 28, 2021

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