Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

May 26, 2009 updated by: Soonchunhyang University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • 1174 Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 420-020
        • Soonchunhyang University, College of medicine Bucheon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: triamcinolone
Drug: triamcinolone acetonide
paste applied over tracheal tube for lubrication
Placebo Comparator: chlorhexidine
Drug: chlorhexidine gluconate
jelly applied over tracheal tube for lubrication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence of postoperative sore throat
Time Frame: postoperative day 1
postoperative day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
the severity of postoperative sore throat
Time Frame: postoperative day 1
postoperative day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 27, 2009

Last Update Submitted That Met QC Criteria

May 26, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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