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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731198
First Posted: August 8, 2008
Last Update Posted: September 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Changhai Hospital
  Purpose
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 Intervention Phase
ERCP Pancreatic Diseases Bile Duct Diseases Drug: Drotaverine hydrochloride Drug: Hyoscine-N-butylbromide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 650
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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
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
Principal Investigator: Zhaoshen Li, MD Changhai Hospital
  More Information

Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00731198     History of Changes
Other Study ID Numbers: Changhai-080615
First Submitted: August 6, 2008
First Posted: August 8, 2008
Results First Submitted: September 14, 2009
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:
Pancreatic Diseases
Bile Duct Diseases
Digestive System Diseases
Biliary Tract Diseases
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Drotaverin
Papaverine
Adjuvants, Anesthesia
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Parasympatholytics
Analgesics
Sensory System Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents


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