NCT00908817

Brief Summary

The purpose of this study is to determine whether triamcinolone paste applied over tracheal tube is effective to reduce the incidence of postoperative sore throat after tracheal intubation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 27, 2009

Completed
Last Updated

May 27, 2009

Status Verified

May 1, 2009

Enrollment Period

11 months

First QC Date

May 21, 2009

Last Update Submit

May 26, 2009

Conditions

Tracheal Intubation

Keywords

postoperative sore throattracheal intubationlubricationtriamcinolone

Outcome Measures

Primary Outcomes (1)

  • the incidence of postoperative sore throat

    postoperative day 1

Secondary Outcomes (1)

  • the severity of postoperative sore throat

    postoperative day 1

Study Arms (2)

triamcinolone

ACTIVE COMPARATOR
Drug: triamcinolone acetonide

chlorhexidine

PLACEBO COMPARATOR
Drug: chlorhexidine gluconate

Interventions

triamcinolone acetonideDRUG

paste applied over tracheal tube for lubrication

triamcinolone
chlorhexidine gluconateDRUG

jelly applied over tracheal tube for lubrication

chlorhexidine

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-II, aged between 20 and 70 years
  • scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation

You may not qualify if:

  • recent respiratory tract infection or sore throat
  • who were using analgesics or steroid preoperatively
  • who have risk factors for oral cavity infection
  • the surgical duration \< 60 minutes or \> 300 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University, College of medicine Bucheon Hospital

1174 Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-do, 420-020, South Korea

Location

Related Publications (1)

  • Park SY, Kim SH, Lee SJ, Chae WS, Jin HC, Lee JS, Kim SI, Hwang KH. Application of triamcinolone acetonide paste to the endotracheal tube reduces postoperative sore throat: a randomized controlled trial. Can J Anaesth. 2011 May;58(5):436-42. doi: 10.1007/s12630-011-9478-6. Epub 2011 Feb 26.

    PMID: 21359615DERIVED

MeSH Terms

Interventions

Triamcinolone Acetonidechlorhexidine gluconate

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2009

First Posted

May 27, 2009

Study Start

May 1, 2008

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

May 27, 2009

Record last verified: 2009-05

Locations

KR(1)