- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04167592
Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP (ERCP)
November 15, 2019 updated by: Adhrie Sugiarto, Indonesia University
Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study was approved by Ethics Committee of Indonesia University.
It was a single-blind randomized clinical trial at Cipto Mangunkusumo Hospital - Jakarta during August to September 2018.
72 subjects were recruited and randomly assigned into 2 groups.
Patients in group B were given 0.15% mouthwash with benzydamine hydrochloride prior to procedure while patients in group C were given mouthwash with 15 ml of water.
Cumulative propofol consumption per minute per kg body weight, and incidence of postoperative sore throat were measured for each group.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Cipto Mangunkusumo General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- undergoing ERCP
- ASA I-III
- BMI 18-30 kg/m2
Exclusion Criteria:
- allergic to propofol
- contraindicated to propofol
- had throat wound or laceration
- received analgesics or steroid in 24 hours priorly
- unstable during sedation
- procedure longer than 90 minutes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Benzydamine Hydrochloride Group
Subjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started.
|
Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
|
Placebo Comparator: Control Group
Subjects who were allocated in control group would gargle with 15 ml of water before sedation started.
|
Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cumulative Propofol Consumption
Time Frame: 90 minutes
|
About 1 mg/kg Propofol was initially administered to sedate the subjects.
If the subject's RSS (Ramsay Sedation Scale) rose, 0.3 mg/kg was additionally given.
The amount of propofol used, as in mg/kg, during the ERCP procedure was recorded.
|
90 minutes
|
Incidence of Sore Throat
Time Frame: 4 hours
|
Sore throat incidence after ERCP procedure was recorded
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adhrie Sugiarto, MD, Indonesia University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.
- Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29. Erratum In: Dig Dis Sci. 2016 Jul;61(7):2146.
- Kati I, Tekin M, Silay E, Huseyinoglu UA, Yildiz H. Does benzydamine hydrochloride applied preemptively reduce sore throat due to laryngeal mask airway? Anesth Analg. 2004 Sep;99(3):710-712. doi: 10.1213/01.ANE.0000133142.52961.8D.
- Sugiarto A, Kapuangan C, Tantri AR, Chrisnata V. Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. BMC Anesthesiol. 2020 May 23;20(1):123. doi: 10.1186/s12871-020-00996-x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2018
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
November 8, 2019
First Submitted That Met QC Criteria
November 15, 2019
First Posted (Actual)
November 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IndonesiaUAnes041
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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