Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

Not Applicable

Completed

• Conditions: ERCP
• Interventions: Drug: Benzydamine Hydrochloride 0.15% Oral Rinse; Drug: Water

• Registration Number: NCT04167592
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2018-09-01
• Study Completion: 2018-10-01
• Status Verified: 2019-11
• Study First Submitted: 2019-11-08
• Study First Submitted QC: 2019-11-15
• Last Update Submitted: 2019-11-15
• Study First Posted: 2019-11-19
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Benzydamine Hydrochloride Group	Benzydamine Hydrochloride 0.15% Oral Rinse	Subjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started.
Control Group	Water	Subjects who were allocated in control group would gargle with 15 ml of water before sedation started.

Primary Outcome Measures

Name	Time	Method
Incidence of Sore Throat	4 hours	Sore throat incidence after ERCP procedure was recorded
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.

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia