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

Endoscopic Ultrasound (EUS) research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Endoscopic Ultrasound (EUS)

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SalineSaline solution injections

Drug:DiphenhydramineDiphenhydramine injections

Drug:PromethazinePromethazine

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Control. Normal Saline Injections.

2Diphenhydramine injections given as adjunct sedative.

3Promethazine given as an adjunct sedative.

Study Status

Unknown status

Start Date: February 2008

Completed Date: September 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Sedation Level

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of California, Irvine

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00937924

Discuss Promethazine