ERCP
Conditions
Keywords
propofol, benzydamine hydrochloride, sore throat, Endoscopic Retrograde Cholangiopancreatography
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.
Interventions
Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
DRUGWater
Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of Sore Throat | 4 hours | Sore throat incidence after ERCP procedure was recorded |
Countries
Indonesia
Outcome results
None listed