Clinical trial NCT04167592: Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP
Official title: Effectivity of Benzydamine Hydrochloride Gargle to Reduce Propofol Consumption in Endoscopic Retrograde Cholangiopancreatography Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ERCP
Keywords: propofol
benzydamine hydrochloride
sore throat
Endoscopic Retrograde Cholangiopancreatography
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Propofol Consumption
timeFrame: 90 minutes
measure: Incidence of Sore Throat
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Adhrie Sugiarto, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
citation: 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.