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

NCT ID: NCT00937924

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Meperidine and midazolam group

Control. Normal Saline Injections.

Group Type: PLACEBO_COMPARATOR

Meperidine, Midazolam

Intervention Type: DRUG

Meperidine and midazolam, plus Diphenhydramine group

Diphenhydramine injections given as adjunct sedative.

Group Type: EXPERIMENTAL

Meperidine, Midazolam

Intervention Type: DRUG

Diphenhydramine

Intervention Type: DRUG

Meperidine and midazolam, plus Promethazne group

Promethazine given as an adjunct sedative.

Group Type: EXPERIMENTAL

Meperidine, Midazolam

Intervention Type: DRUG

Promethazine

Intervention Type: DRUG

Interventions

Meperidine, Midazolam

Intervention Type: DRUG

Diphenhydramine

Intervention Type: DRUG

Promethazine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Kenneth J. Chang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Chang, MD

Role: PRINCIPAL_INVESTIGATOR

UC Irvine

Locations

H.H. Chao Comprehensive Digestive Disease Center

Orange, California, United States

Countries

United States

Other Identifiers

20075810

Identifier Type: -

Identifier Source: org_study_id