Clinical trial NCT00937924: Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Endoscopic Ultrasound (EUS)
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Keywords: EUS
ERCP
Sedation Level
Adverse Symptoms
Recovery time
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2009-07-13
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Average Percentage of Sedation Failures
timeFrame: From onset of sedation to completion of procedure, approximately 1 hour.
measure: Time to Achieve Adequate Level of Sedation to Begin Procedure
timeFrame: Pre-Endoscopic Procedure (up to 1 hour maximum)
measure: Time for Recovery
timeFrame: Post-Endoscopic Procedure
Secondary outcomes:
measure: Adverse Symptoms From Sedative Agents
timeFrame: Approximately 3 hours.
Other outcomes:
Locations:
city: Orange
country: United States
facility: H.H. Chao Comprehensive Digestive Disease Center
state: California
Study officials:
affiliation: UC Irvine
name: Kenneth Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: