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

August 31, 2010 updated by: Changhai Hospital

Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Fuzhou, China
        • Fujian Provincial Hospital
      • Hangzhou, China
        • The First People's Hospital of Hangzhou
      • Harbin, China
        • Heilongjiang Provincial Hospital
      • Shanghai, China
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drotaverine hydrochloride
Drug: Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other Names:
  • No-spa
Active Comparator: 2
Hyoscine-N-butylbromide
Drug: Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other Names:
  • Scopolamine Butylbromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intra-procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Cannulation Time
Time Frame: Intra-procedure
Intra-procedure
Percentage of Successful Selective Cannulation
Time Frame: Intra-procedure
Intra-procedure
Frequency of Post-ERCP Complications
Time Frame: 48 hours after ERCP
48 hours after ERCP
Side Effects
Time Frame: Intra-procedure and 24 hours after ERCP
Intra-procedure and 24 hours after ERCP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, MD, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

August 31, 2010

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Changhai-080615

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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