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Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00908817
Recruitment Status : Completed
First Posted : May 27, 2009
Last Update Posted : May 27, 2009
Sponsor:
Information provided by:
Soonchunhyang University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tracheal Intubation Drug: triamcinolone acetonide Drug: chlorhexidine gluconate Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of postoperative sore throat [ Time Frame: postoperative day 1 ]

Secondary Outcome Measures :
  1. the severity of postoperative sore throat [ Time Frame: postoperative day 1 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00908817


Locations
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Korea, Republic of
Soonchunhyang University, College of medicine Bucheon Hospital
1174 Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 420-020
Sponsors and Collaborators
Soonchunhyang University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Park Sun-Young, Soonchunhyang University, College of medicine Bucheon Hospital
ClinicalTrials.gov Identifier: NCT00908817    
Other Study ID Numbers: ST
First Posted: May 27, 2009    Key Record Dates
Last Update Posted: May 27, 2009
Last Verified: May 2009
Keywords provided by Soonchunhyang University Hospital:
postoperative sore throat
tracheal intubation
lubrication
triamcinolone
Additional relevant MeSH terms:
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Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Chlorhexidine
Chlorhexidine gluconate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
 Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action