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

Endoscopic Retrograde Cholangiopancreatography (ERCP) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00937924
• Other study ID #: 20075810
• Status: Completed
• Phase: Phase 4
• Start date: February 2008
• Est. completion date: June 2012

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endoscopic Retrograde Cholangiopancreatography (ERCP)
• Endoscopic Ultrasound (EUS)

Intervention

Drug:
• Meperidine, Midazolam

• Diphenhydramine

• Promethazine

Locations

Country	Name	City	State
United States	H.H. Chao Comprehensive Digestive Disease Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Percentage of Sedation Failures	The percentage of participants who could not complete the procedure due inability to achieve proper sedation level	From onset of sedation to completion of procedure, approximately 1 hour.
Primary	Time to Achieve Adequate Level of Sedation to Begin Procedure		Pre-Endoscopic Procedure (up to 1 hour maximum)
Primary	Time for Recovery		Post-Endoscopic Procedure
Secondary	Adverse Symptoms From Sedative Agents		Approximately 3 hours.