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

Condition(s) targeted: Endoscopic Ultrasound (EUS); Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention: Saline (Drug); Diphenhydramine (Drug); Promethazine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of California, Irvine

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

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Sedation Level

Time to achieve adequate level of sedation to begin procedure

Time for Recovery

Adverse Symptoms From Sedative Agents

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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

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

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

Starting date: February 2008
Last updated: February 10, 2011