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Completed

NCT Number: NCT04167592

Benzydamine Hydrochloride Gargle in Reducing Propofol for ERCP

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

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Key information

Conditions

ERCP Infections Otorhinolaryngologic Diseases Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benzydamine Hydrochloride 0.15% Oral Rinse

Drug

Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.

Water

Drug

Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.

Primary outcomes

  1. Cumulative Propofol Consumption

    Time frame: 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.

  2. Incidence of Sore Throat

    Time frame: 4 hours

    Sore throat incidence after ERCP procedure was recorded

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Acronym: ERCP

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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