Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial

Last registered on July 05, 2014
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Pre-Trial

Trial Information

General Information

Title
Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial
RCT ID
AEARCTR-0000430
First published
July 05, 2014, 10:42 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Turkey
Region

Primary Investigator

Name
Barış Sevinç
Affiliation
Konya Training and Research Hospital
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Other Primary Investigator(s)

PI Name
Serden Ay
PI Affiliation
Konya Training and Research Hospital
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PI Name
Nergis Aksoy
PI Affiliation
Konya Training and Research Hospital
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PI Name
Ömer Karahan
PI Affiliation
Konya Training and Research Hospital
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PI Name
Ahmet Okuş
PI Affiliation
Mevlana University Medical School
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Additional Trial Information

Status
Completed
Start date
2013-04-01
End date
2013-09-30
Keywords
Health
Additional Keywords
JEL code(s)
Secondary IDs
Abstract
Background: Otilonium Bromide is a safe spasmolytic agent. The aim of this study is to determine the effect of otilonium bromide in upper gastrointestinal endoscopy.
Methods: The study was initiated as randomized and prospective in single center by experienced endoscopists. The patients were randomized into spasmolytic and control groups. In spasmolytic group, patients were administered 80 mg of otilonium bromide orally, 2 hours before the procedure. The control group took no medicine.
Upper gastrointestinal endoscopy was performed under topical anesthesia without any sedation. The endoscopist evaluated the motility and tolerability of the procedure. Moreover, another person evaluated the patients’ comments on the procedure.
Results: There were 400 patients included into the study (257 female and 143 male). The mean age was 51.8 years. In the spasmolytic group, the tolerability of the procedure was evaluated as bad in 10%, moderate in 38% and good and very good in 52% of the procedures. In the control group, those rates were 21%, 53.5% and 30%, respectively (p<0.001).
In the spasmolytic group, intestinal motility was evaluated as no in 13%, mild in 70% and moderate in 17% of the procedures. In the control group the rates were as follows: 11.5%, 53.5% and 35% (p<0.001).
Conclusions: Otilonium bromide decreases the intestinal motility and can be used safely as a spasmolytic before the upper gastrointestinal system endoscopy. It can ease the procedure both for the endoscopist and the patient.
External Link(s)

Registration Citation

Citation
Aksoy, Nergis et al. 2014. "Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial." AEA RCT Registry. July 05. https://doi.org/10.1257/rct.430-1.0
Former Citation
Aksoy, Nergis et al. 2014. "Spasmolytic (Otilonium Bromide) Use in Upper Gastrointestinal Endoscopy: Randomized Prospective Trial." AEA RCT Registry. July 05. https://www.socialscienceregistry.org/trials/430/history/2071
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
The Patients with any indication for upper astrointestinal endoscopic 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
2013-09-30

Primary Outcomes

Primary Outcomes (end points)
The key outcomes of the study are as follows; 1. Patient's satisfaction about the procedure 2. Endoscopist's satisfaction about the procedure 3. Gastrik motility
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. Moreover, the procedures under sedation cases with disorders decreasing the intestinal motility like hypothyroidism and diabetes will be excluded. 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.
Endoscopy procedures will be performed under routine topical anesthesia without sedation. Endoscopist will evaluate the intestinal motility (no, mild, moderate and severe), patients tolerability (bad, moderate, good and very good).
The motility will be evaluated according to the following scale; no: if there is no motility or mild peristaltic movements that does not obstruct the lumen, mild: if there are 1-3 non-obstructive contractions, moderate: if there are 1-3 obstructive contractions that needs to wait for the contraction to pass to continue the procedure, severe: if more than 3 contractions that obstruct the gastric lumen.
Another person from the endoscopist will ask the patients for the tolerability of the procedure (bad, moderate, good, very good). The endoscopist and the other assistant will not know the groups.
Experimental Design Details
Randomization Method
consecutively
Randomization Unit
cases
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
400 cases
Sample size: planned number of observations
400 procedures
Sample size (or number of clusters) by treatment arms
200 cases for contrl and 200 cases for the study group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Ministry of Health of Turkey Ethical Commitee
IRB Approval Date
2013-05-07
IRB Approval Number
26247030-514-04-03
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials