Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

ERCP Clinical Trial

— ERCP  

Official title:

Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04167592
• Other study ID #: IndonesiaUAnes041
• Status: Completed
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: November 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ERCP

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (3)

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):710-2, table of contents. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Propofol Consumption	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
Primary	Incidence of Sore Throat	Sore throat incidence after ERCP procedure was recorded	4 hours