NCT04167592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 8, 2019

Last Update Submit

November 15, 2019

Conditions

ERCP

Keywords

propofolbenzydamine hydrochloridesore throatEndoscopic Retrograde Cholangiopancreatography

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Benzydamine Hydrochloride Group

ACTIVE COMPARATOR

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

Control Group

PLACEBO COMPARATOR

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

Drug: Water

Interventions

Benzydamine Hydrochloride 0.15% Oral RinseDRUG

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

Benzydamine Hydrochloride Group
WaterDRUG

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • undergoing ERCP
  • ASA I-III
  • BMI 18-30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (4)

  • Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463.

    PMID: 23382625BACKGROUND

  • Yang JF, Farooq P, Zwilling K, Patel D, Siddiqui AA. Efficacy and Safety of Propofol-Mediated Sedation for Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). Dig Dis Sci. 2016 Jun;61(6):1686-91. doi: 10.1007/s10620-016-4043-3. Epub 2016 Jan 29.

    PMID: 26825844BACKGROUND

  • Kati I, Tekin M, Silay E, Huseyinoglu UA, Yildiz H. Does benzydamine hydrochloride applied preemptively reduce sore throat due to laryngeal mask airway? Anesth Analg. 2004 Sep;99(3):710-712. doi: 10.1213/01.ANE.0000133142.52961.8D.

    PMID: 15333399BACKGROUND

  • Sugiarto A, Kapuangan C, Tantri AR, Chrisnata V. Effectivity of benzydamine hydrochloride gargle to reduce propofol consumption in endoscopic retrograde cholangiopancreatography procedure: a randomized controlled trial. BMC Anesthesiol. 2020 May 23;20(1):123. doi: 10.1186/s12871-020-00996-x.

    PMID: 32446304DERIVED

MeSH Terms

Conditions

Pharyngitis

Interventions

BenzydamineMouthwashesWater

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

IndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and AgricultureHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Adhrie Sugiarto, MD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Staff

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 19, 2019

Study Start

August 1, 2018

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)