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Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

Primary Purpose

Tracheal Intubation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
triamcinolone acetonide
chlorhexidine gluconate
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tracheal Intubation focused on measuring postoperative sore throat, tracheal intubation, lubrication, triamcinolone

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Soonchunhyang University, College of medicine Bucheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

triamcinolone

chlorhexidine

Arm Description

Outcomes

Primary Outcome Measures

the incidence of postoperative sore throat

Secondary Outcome Measures

the severity of postoperative sore throat

Full Information

First Posted
May 21, 2009
Last Updated
May 26, 2009
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00908817
Brief Title
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
Official Title
Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Sore throat is a common postoperative complaint after tracheal intubation. When the surgical pain is well controlled, sore throat is often the predominant complaint, therefore it is important to prevent sore throat.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tracheal Intubation
Keywords
postoperative sore throat, tracheal intubation, lubrication, triamcinolone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
triamcinolone
Arm Type
Active Comparator
Arm Title
chlorhexidine
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
triamcinolone acetonide
Intervention Description
paste applied over tracheal tube for lubrication
Intervention Type
Drug
Intervention Name(s)
chlorhexidine gluconate
Intervention Description
jelly applied over tracheal tube for lubrication
Primary Outcome Measure Information:
Title
the incidence of postoperative sore throat
Time Frame
postoperative day 1
Secondary Outcome Measure Information:
Title
the severity of postoperative sore throat
Time Frame
postoperative day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
Inclusion Criteria: ASA physical status I-II, aged between 20 and 70 years scheduled for elective laparoscopic cholecystectomy under general anesthesia with endotracheal intubation Exclusion Criteria: 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
Facility Information:
Facility Name
Soonchunhyang University, College of medicine Bucheon Hospital
City
1174 Jung-Dong, Wonmi-Gu, Bucheon-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
420-020
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21359615
Citation
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.
Results Reference
derived

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Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

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