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

Naval Military Medical University

Status and phase: Completed; Phase 3

Conditions: ERCP; Pancreatic Diseases; Bile Duct Diseases

Treatments: Drug: Drotaverine hydrochloride; Drug: Hyoscine-N-butylbromide

Study type: Interventional

Funder types: Other

Identifiers

NCT00731198

Changhai-080615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups

1

Experimental group

Description:

Drotaverine hydrochloride

Treatment:

Drug: Drotaverine hydrochloride

2

Active Comparator group

Description:

Hyoscine-N-butylbromide

Treatment:

Drug: Hyoscine-N-butylbromide