Otilonium Bromide as Spasmolytic during Endoscopic Retrograde Cholangiopancreatography
Last registered on July 04, 2014

Pre-Trial

Trial Information
General Information
Title
Otilonium Bromide as Spasmolytic during Endoscopic Retrograde Cholangiopancreatography
RCT ID
AEARCTR-0000429
Initial registration date
July 04, 2014
Last updated
July 04, 2014 2:35 PM EDT
Location(s)
Region
Primary Investigator
Affiliation
Konya Training and Research Hospital
Other Primary Investigator(s)
PI Affiliation
Konya Training and Research Hospital
PI Affiliation
Konya Training and Research Hospital
PI Affiliation
Mevlana University Medical School
PI Affiliation
Konya Training and Research Hospital
Additional Trial Information
Status
Completed
Start date
2013-04-01
End date
2013-08-30
Secondary IDs
Abstract
Background: Endoscopic retrograde cholangiopancreatography (ERCP) is commonly used in diagnosis and treatment of biliary and pancreatic disorders. The aim of this study is to evaluate the effects of OB use during ERCP on duodenal motility, the tolerability of the procedure (by patients) and the difficulty of the procedure (by the endoscopist).


Method: The study was enrolled in Konya Training and Research Hospital General Surgery Endoscopy Unit in randomized prospective pattern. The patients were divided into two groups as spasmolytic and control groups. The procedure was performed under topical anesthesia and sedation.

Results: There were 100 cases included into the study (50 cases in each group). The mean duodenal motility score was found to be 1.9 ± 0.5 in the study group and 3 ±0.6 in the control group. In the study group, the tolerability of the procedure score by the endoscopist was moderate in 16% and well/very well in 78% of the cases. On the other hand, in the control group, the scores were poor in 21%, moderate in 71% and well /very well in 24% of the cases. In terms of patient satisfaction, in study group 42% of the cases reported the procedure as moderate and 58% reported as well/very well. However, in the control group 16% of the cases reported the procedure as poor, 58% moderate and 26% as well/very well.

Conclusion: Otilonium bromide is a safe agent with low side effects. It can be used before the ERCP procedure to decrease the duodenal motility. It eases the procedure, moreover, it increases the patients’ satisfaction.
External Link(s)
Registration Citation
Citation
Aksoy, Nergis et al. 2014. "Otilonium Bromide as Spasmolytic during Endoscopic Retrograde Cholangiopancreatography ." AEA RCT Registry. July 04. https://www.socialscienceregistry.org/trials/429/history/2059
Experimental Details
Interventions
Intervention(s)
The Patients with any indication for endoscopic retrograde cholangiopancreaticography will be evaluated for the study. After an informed consent cases with no known allergy to otilonium bromide will be included in the study. The patients will be divided into 2 groups as drug group and control group randomly. patients in drug group will be given two tablets of 20 mg otilonium bromide orally 2 hours before the procedure. patients in control group will receive no additional intervention.
Intervention Start Date
2013-04-01
Intervention End Date
2013-08-30
Primary Outcomes
Primary Outcomes (end points)
The key outcomes of the study are as follows;
1. Duodenal motility
2. Patient's satisfaction about the procedure
3. Endoscopist's satisfaction about the procedure
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The patients above 18 years of age who accepted to be involved in the study and with no known allergy to the agent will be included to the study. Emergent cases, cases with low mental status and the pregnant women will be excluded from the study. To all the patients the design of the study will be explained and written consent will be taken. Another resident will divide the patients into spasmolytic (study) and control group consecutively. To the patients in study group, 2 tablets of OB (2x40 mg otilonium bromide) will be given as to take with a little water 2 hours before the procedure, orally. No drugs will be given to control group.
The ERCP procedures will be performed under routine topical anesthesia and sedation. For the sedation 0.1 mg/kg midazolam (Dormicum amp, Roche) will be administered intravenously. As the endoscopist would not know the groups, during the procedure IV hyoscine-n-butylbromide (Buscopan amp, Zentiva) will be administered according to the endoscopist’ wish. During the procedure another resident will score the duodenal motility from 1 to 5 according to the following scale:
1: no contraction
2: less than 5 contractions in a minute
3: 5-10 contractions /minute
4: 11-15 contractions /minute
5: continued contractions
At the end of the procedure the endoscopist will score the patients’ tolerability procedure as poor, moderate, well or very well.
After the procedure another resident will ask the patients’ satisfaction as poor, moderate, well or very well. The co-workers who take the informed consent, randomize the patients into groups, score the motility and make the analysis will be independent from each other and will not know the groups.
Experimental Design Details
Randomization Method
consecutively
Randomization Unit
individual
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
100 cases
Sample size: planned number of observations
100 cases
Sample size (or number of clusters) by treatment arms
50 cases control, 50 cases for the drug
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Ministry of Health of Turkey Ethical Commitee
IRB Approval Date
2013-05-07
IRB Approval Number
26247029-514-04-03
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers