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Completed

NCT Number: NCT00731198

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujian Provincial Hospital, Fuzhou, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Drotaverine hydrochloride

Drug

Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP

Other names: No-spa

Hyoscine-N-butylbromide

Drug

Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.

Other names: Scopolamine Butylbromide

Primary outcomes

  1. 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 outcomes

  1. Cannulation Time

    Time frame: Intra-procedure

  2. Percentage of Successful Selective Cannulation

    Time frame: Intra-procedure

  3. Frequency of Post-ERCP Complications

    Time frame: 48 hours after ERCP

  4. Side Effects

    Time frame: Intra-procedure and 24 hours after ERCP

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Sep 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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