Adjunct Sedatives in Procedures Involving Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) - Full Text View

Sponsor:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00937924

Purpose

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Endoscopy Ultrasound

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Diphenhydramine hydrochloride Diphenhydramine citrate

U.S. FDA Resources

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

Primary Outcome Measures:

Sedation Level [ Time Frame: Pre-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
Time to achieve adequate level of sedation to begin procedure [ Time Frame: Pre-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
Time for Recovery [ Time Frame: Post-Endoscopic Procedure ] [ Designated as safety issue: Yes ]
Adverse Symptoms From Sedative Agents [ Time Frame: Pre/post Endoscopic Procedure ] [ Designated as safety issue: Yes ]

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Dr. Venkataraman Muthusamy, Department of Gastroenterology
ClinicalTrials.gov Identifier:	NCT00937924 History of Changes
Other Study ID Numbers:	HS 2007-5810
Study First Received:	June 4, 2008
Last Updated:	February 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

EUS
ERCP
Sedation Level
Adverse Symptoms
Recovery time

Additional relevant MeSH terms:

Diphenhydramine
Promethazine
Hypnotics and Sedatives
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 23, 2012