Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
|ClinicalTrials.gov Identifier: NCT00731198|
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : December 23, 2009
Last Update Posted : September 8, 2010
|Condition or disease||Intervention/treatment||Phase|
|ERCP Pancreatic Diseases Bile Duct Diseases||Drug: Drotaverine hydrochloride Drug: Hyoscine-N-butylbromide||Phase 3|
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.
Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||July 2009|
Drug: Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other Name: No-spa
Active Comparator: 2
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other Name: Scopolamine Butylbromide
- The Grades of the Number of Duodenal Contractions [ Time Frame: Intra-procedure ]a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
- Cannulation Time [ Time Frame: Intra-procedure ]
- Percentage of Successful Selective Cannulation [ Time Frame: Intra-procedure ]
- Frequency of Post-ERCP Complications [ Time Frame: 48 hours after ERCP ]
- Side Effects [ Time Frame: Intra-procedure and 24 hours after ERCP ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731198
|Fujian Provincial Hospital|
|The First People's Hospital of Hangzhou|
|Heilongjiang Provincial Hospital|
|Changhai Hospital, Second Military Medical University|
|Principal Investigator:||Zhaoshen Li, MD||Changhai Hospital|