Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
NCT ID: NCT00731198
Last Updated: 2010-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2008-08-31
2009-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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1
Drotaverine hydrochloride
Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
2
Hyoscine-N-butylbromide
Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Interventions
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Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known previous sphincterotomy
* Active acute pancreatitis before ERCP
* Ongoing acute cholangitis before ERCP
* Hypotension (systolic blood pressure \< 100 mmHg)
* Second-degree and third-degree atrioventricular block
* Heart failure
* Glaucoma
* Obstructive uropathy
* Impaired renal function (serum creatinine \> 133μmol/L)
* Pregnant or breastfeeding women
18 Years
90 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Changhai Hospital, Second Military Medical University
Principal Investigators
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Zhaoshen Li, MD
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Locations
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Fujian Provincial Hospital
Fuzhou, , China
The First People's Hospital of Hangzhou
Hangzhou, , China
Heilongjiang Provincial Hospital
Harbin, , China
Changhai Hospital, Second Military Medical University
Shanghai, , China
Countries
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Other Identifiers
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Changhai-080615
Identifier Type: -
Identifier Source: org_study_id