Drotaverine hydrochloride
DrugDrotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other names: No-spa
NCT Number: NCT00731198
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.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 3
Fujian Provincial Hospital, Fuzhou, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other names: No-spa
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other names: Scopolamine Butylbromide
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.
Time frame: Intra-procedure
Time frame: Intra-procedure
Time frame: 48 hours after ERCP
Time frame: Intra-procedure and 24 hours after ERCP
Changhai Hospital
Other
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
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