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Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)

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ClinicalTrials.gov Identifier: NCT00731198
Recruitment Status : Completed
First Posted : August 8, 2008
Results First Posted : December 23, 2009
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Changhai Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
ERCP Pancreatic Diseases Bile Duct Diseases Drug: Drotaverine hydrochloride Drug: Hyoscine-N-butylbromide Phase 3

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Drotaverine hydrochloride
 Drug: Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other Name: No-spa
Active Comparator: 2
Hyoscine-N-butylbromide
 Drug: Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other Name: Scopolamine Butylbromide


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cannulation Time [ Time Frame: Intra-procedure ]
  2. Percentage of Successful Selective Cannulation [ Time Frame: Intra-procedure ]
  3. Frequency of Post-ERCP Complications [ Time Frame: 48 hours after ERCP ]
  4. Side Effects [ Time Frame: Intra-procedure and 24 hours after ERCP ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients undergoing ERCP above the age of 18 years

Exclusion Criteria:

  • Patient with Billroth II gastrectomy
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00731198


Locations
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China
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
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Zhaoshen Li, MD Changhai Hospital
More Information
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Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00731198    
Other Study ID Numbers: Changhai-080615
First Posted: August 8, 2008    Key Record Dates
Results First Posted: December 23, 2009
Last Update Posted: September 8, 2010
Last Verified: November 2009
Keywords provided by Changhai Hospital:
ERCP
Drotaverine hydrochloride
Hyoscine-N-butylbromide
Additional relevant MeSH terms:
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Pancreatic Diseases
Bile Duct Diseases
Digestive System Diseases
Biliary Tract Diseases
Drotaverin
Scopolamine
Butylscopolammonium Bromide
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Mydriatics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Analgesics
Sensory System Agents
Vasodilator Agents