Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

Study Overview
=================
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.

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

Conditions
-----------------
ERCP

Intervention / Treatment
-----------------
* Drug: Benzydamine Hydrochloride 0.15% Oral Rinse
* Drug: Water


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Benzydamine Hydrochloride Group<br>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<br>* Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.<br>|
| Placebo Comparator: Control Group<br>Subjects who were allocated in control group would gargle with 15 ml of water before sedation started. | Drug: Water<br>* Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Incidence of Sore Throat | Sore throat incidence after ERCP procedure was recorded | 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
propofol, benzydamine hydrochloride, sore throat, Endoscopic Retrograde Cholangiopancreatography