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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Endoscopic Ultrasound (EUS), Endoscopic Retrograde Cholangiopancreatography (ERCP)

Intervention / Treatment
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* Drug: Saline
* Drug: Diphenhydramine
* Drug: Promethazine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Control. Normal Saline Injections. | Drug: Saline<br>* Saline solution injections<br>|
| Experimental: 2<br>Diphenhydramine injections given as adjunct sedative. | Drug: Diphenhydramine<br>* Diphenhydramine injections<br>|
| Experimental: 3<br>Promethazine given as an adjunct sedative. | Drug: Promethazine<br>* Promethazine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation Level |  | Pre-Endoscopic Procedure | 
| Time to achieve adequate level of sedation to begin procedure |  | Pre-Endoscopic Procedure | 
| Time for Recovery |  | Post-Endoscopic Procedure | 
| Adverse Symptoms From Sedative Agents |  | Pre/post Endoscopic Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EUS, ERCP, Sedation Level, Adverse Symptoms, Recovery time