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

This study has been completed.
Sponsor:
Information provided by:
Changhai Hospital
ClinicalTrials.gov Identifier:
NCT00731198
First received: August 6, 2008
Last updated: August 31, 2010
Last verified: November 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percentage of Successful Selective Cannulation [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
  • Frequency of Post-ERCP Complications [ Time Frame: 48 hours after ERCP ] [ Designated as safety issue: Yes ]
  • Side Effects [ Time Frame: Intra-procedure and 24 hours after ERCP ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Second Military Medical University
  More Information

No publications provided

Responsible Party: Zhaoshen Li, Changhai Hospital, Second Military Medical University
ClinicalTrials.gov Identifier: NCT00731198     History of Changes
Other Study ID Numbers: Changhai-080615
Study First Received: August 6, 2008
Results First Received: September 14, 2009
Last Updated: August 31, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
ERCP
Drotaverine hydrochloride
Hyoscine-N-butylbromide

Additional relevant MeSH terms:
Bile Duct Diseases
Pancreatic Diseases
Biliary Tract Diseases
Digestive System Diseases
Butylscopolammonium Bromide
Drotaverin
Papaverine
Scopolamine Hydrobromide
Adjuvants, Anesthesia
Analgesics
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014