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