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
|Condition or disease||Intervention/treatment||Phase|
|Endoscopic Ultrasound (EUS) Endoscopic Retrograde Cholangiopancreatography (ERCP)||Drug: Saline Drug: Diphenhydramine Drug: Promethazine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||465 participants|
|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|
Placebo Comparator: 1
Control. Normal Saline Injections.
Saline solution injections
Diphenhydramine injections given as adjunct sedative.
Promethazine given as an adjunct sedative.
- 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 ]
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
|Contact: Venkataraman Muthusamy, MD||714 email@example.com|
|Contact: Swapna Reddy, MDfirstname.lastname@example.org|
|United States, California|
|H.H. Chao Comprehensive Digestive Disease Center||Recruiting|
|Orange, California, United States, 92868|