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

August 6, 2008
August 31, 2010
August 2008
March 2009   (final data collection date for primary outcome measure)
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.
The number of duodenal contractions [ Time Frame: Intra-procedure ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00731198 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • ERCP
  • Pancreatic Diseases
  • Bile Duct Diseases
  • Drug: Drotaverine hydrochloride
    Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
    Other Name: No-spa
  • Drug: Hyoscine-N-butylbromide
    Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
    Other Name: Scopolamine Butylbromide
  • Experimental: 1
    Drotaverine hydrochloride
    Intervention: Drug: Drotaverine hydrochloride
  • Active Comparator: 2
    Hyoscine-N-butylbromide
    Intervention: Drug: Hyoscine-N-butylbromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
July 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00731198
Changhai-080615
Yes
Zhaoshen Li, Changhai Hospital, Second Military Medical University
Changhai Hospital
Not Provided
Principal Investigator: Zhaoshen Li, MD Changhai Hospital, Second Military Medical University
Changhai Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP