Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04167592
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 35.9

Study Details

Study Description

Brief Summary

It was a study aimed to determine the effectivity of benzydamine hydrochloride gargling in reducing propofol consumption in the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.

Condition or Disease	Intervention/Treatment	Phase
ERCP	Drug: Benzydamine Hydrochloride 0.15% Oral Rinse; Drug: Water	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Sep 1, 2018
• Actual Study Completion Date: Oct 1, 2018

Arms and Interventions

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.	Drug: Benzydamine Hydrochloride 0.15% Oral Rinse; 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.	Drug: Water; Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.

Outcome Measures

Primary Outcome Measures

1. Cumulative Propofol Consumption [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.

2. Incidence of Sore Throat [4 hours]

   Sore throat incidence after ERCP procedure was recorded

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Adhrie Sugiarto, MD, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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. Review.
• 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.

• Responsible Party: Adhrie Sugiarto, Medical Staff, Indonesia University
• ClinicalTrials.gov Identifier: NCT04167592
• Other Study ID Numbers: IndonesiaUAnes041
• First Posted: Nov 19, 2019
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Adhrie Sugiarto, Medical Staff, Indonesia University: propofol; benzydamine hydrochloride; sore throat; Endoscopic Retrograde Cholangiopancreatography
• Additional relevant MeSH terms: Benzydamine

Study Results

No Results Posted as of Nov 19, 2019