Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

University of Indonesia (UI)

Status: Completed

Conditions: ERCP

Treatments: Drug: Water; Drug: Benzydamine Hydrochloride 0.15% Oral Rinse

Study type: Interventional

Funder types: Other

Identifiers

NCT04167592

IndonesiaUAnes041

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

72 participants in 2 patient groups, including a placebo group

Benzydamine Hydrochloride Group

Active Comparator group

Description:

Subjects who were allocated in benzydamine group would gargle with 15 of ml benzydamine hydrochloride 0.15% before sedation started.

Treatment:

Drug: Benzydamine Hydrochloride 0.15% Oral Rinse

Control Group

Placebo Comparator group

Description:

Subjects who were allocated in control group would gargle with 15 ml of water before sedation started.

Treatment:

Drug: Water