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Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

This study has been completed.
Sponsor:
Information provided by:
Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT00908817
First received: May 21, 2009
Last updated: May 26, 2009
Last verified: May 2009
  Purpose

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 Intervention
Tracheal Intubation
Drug: triamcinolone acetonide
Drug: chlorhexidine gluconate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Triamcinolone Paste to Reduce the Incidence of Postoperative Sore Throat

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • the incidence of postoperative sore throat [ Time Frame: postoperative day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the severity of postoperative sore throat [ Time Frame: postoperative day 1 ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908817

Locations
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

No publications provided by Soonchunhyang University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Park Sun-Young, Soonchunhyang University, College of medicine Bucheon Hospital
ClinicalTrials.gov Identifier: NCT00908817     History of Changes
Other Study ID Numbers: ST
Study First Received: May 21, 2009
Last Updated: May 26, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:
postoperative sore throat
tracheal intubation
lubrication
triamcinolone

Additional relevant MeSH terms:
Pharyngitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Infective Agents
Anti-Infective Agents, Local
Anti-Inflammatory Agents
Dermatologic Agents
Disinfectants
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014