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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2011 by University of California, Irvine.
Recruitment status was:  Recruiting
Information provided by:
University of California, Irvine Identifier:
First received: June 4, 2008
Last updated: February 10, 2011
Last verified: February 2011
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 Intervention
Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP) Drug: Saline Drug: Diphenhydramine Drug: Promethazine

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by University of California, Irvine:

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

Estimated Enrollment: 465
Study Start Date: February 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00937924

Contact: Venkataraman Muthusamy, MD 714 456-5765
Contact: Swapna Reddy, MD

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

Responsible Party: Dr. Venkataraman Muthusamy, Department of Gastroenterology Identifier: NCT00937924     History of Changes
Other Study ID Numbers: HS 2007-5810
Study First Received: June 4, 2008
Last Updated: February 10, 2011

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

Additional relevant MeSH terms:
Hypnotics and Sedatives
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Dermatologic Agents processed this record on September 21, 2017