Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
ERCP Pancreatic Diseases Bile Duct Diseases |
Drug: Drotaverine hydrochloride Drug: Hyoscine-N-butylbromide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial |
- 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.
- 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 ]
| Enrollment: | 650 |
| Study Start Date: | August 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Drotaverine hydrochloride
|
Drug: Drotaverine hydrochloride
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Other Name: No-spa
|
|
Active Comparator: 2
Hyoscine-N-butylbromide
|
Drug: Hyoscine-N-butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
Other Name: Scopolamine Butylbromide
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China | |
| Fujian Provincial Hospital | |
| Fuzhou, China | |
| The First People's Hospital of Hangzhou | |
| Hangzhou, China | |
| Heilongjiang Provincial Hospital | |
| Harbin, China | |
| Changhai Hospital, Second Military Medical University | |
| Shanghai, China | |
| Principal Investigator: | Zhaoshen Li, MD | Changhai Hospital, Second Military Medical University |
More Information
No publications provided
| Responsible Party: | Zhaoshen Li, Changhai Hospital, Second Military Medical University |
| ClinicalTrials.gov Identifier: | NCT00731198 History of Changes |
| Other Study ID Numbers: | Changhai-080615 |
| Study First Received: | August 6, 2008 |
| Results First Received: | September 14, 2009 |
| Last Updated: | August 31, 2010 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Changhai Hospital:
|
ERCP Drotaverine hydrochloride Hyoscine-N-butylbromide |
Additional relevant MeSH terms:
|
Bile Duct Diseases Pancreatic Diseases Biliary Tract Diseases Digestive System Diseases Butylscopolammonium Bromide Drotaverin Scopolamine Papaverine Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Mydriatics Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Analgesics Sensory System Agents Vasodilator Agents Cardiovascular Agents Phosphodiesterase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013