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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Changhai Hospital

Current Primary Outcome: 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.


Original Primary Outcome: The number of duodenal contractions [ Time Frame: Intra-procedure ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Changhai Hospital

Dates:
Date Received: August 6, 2008
Date Started: August 2008
Date Completion:
Last Updated: August 31, 2010
Last Verified: November 2009