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

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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ERCP, Pancreatic Diseases, Bile Duct Diseases

Intervention / Treatment
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* Drug: Drotaverine hydrochloride
* Drug: Hyoscine-N-butylbromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drotaverine hydrochloride | Drug: Drotaverine hydrochloride<br>* Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP<br>* Other names: No-spa;|
| Active Comparator: 2<br>Hyoscine-N-butylbromide | Drug: Hyoscine-N-butylbromide<br>* Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.<br>* Other names: Scopolamine Butylbromide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Grades of the Number of Duodenal Contractions | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation Time |  | Intra-procedure | 
| Percentage of Successful Selective Cannulation |  | Intra-procedure | 
| Frequency of Post-ERCP Complications |  | 48 hours after ERCP | 
| Side Effects |  | Intra-procedure and 24 hours after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide