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

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ClinicalTrials.gov Identifier: NCT00937924
Recruitment Status : Unknown
Verified February 2011 by University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : July 13, 2009
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
University of California, Irvine

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.

Condition or disease Intervention/treatment
Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP) Drug: Saline Drug: Diphenhydramine Drug: Promethazine

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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 Start Date : February 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010


Arm Intervention/treatment
Placebo Comparator: 1
Control. Normal Saline Injections.
Drug: Saline
Saline solution injections
Experimental: 2
Diphenhydramine injections given as adjunct sedative.
Drug: Diphenhydramine
Diphenhydramine injections
Experimental: 3
Promethazine given as an adjunct sedative.
Drug: Promethazine
Promethazine



Primary Outcome Measures :
  1. Sedation Level [ Time Frame: Pre-Endoscopic Procedure ]
  2. Time to achieve adequate level of sedation to begin procedure [ Time Frame: Pre-Endoscopic Procedure ]
  3. Time for Recovery [ Time Frame: Post-Endoscopic Procedure ]
  4. Adverse Symptoms From Sedative Agents [ Time Frame: Pre/post Endoscopic Procedure ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937924


Contacts
Contact: Venkataraman Muthusamy, MD 714 456-5765 raman@uci.edu
Contact: Swapna Reddy, MD sbreddy@uci.edu

Locations
United States, California
H.H. Chao Comprehensive Digestive Disease Center Recruiting
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine

Responsible Party: Dr. Venkataraman Muthusamy, Department of Gastroenterology
ClinicalTrials.gov Identifier: NCT00937924     History of Changes
Other Study ID Numbers: HS 2007-5810
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2011

Keywords provided by University of California, Irvine:
EUS
ERCP
Sedation Level
Adverse Symptoms
Recovery time

Additional relevant MeSH terms:
Diphenhydramine
Promethazine
Hypnotics and Sedatives
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Antipruritics
Dermatologic Agents