Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01308320
First received: March 3, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 3, 2011
March 3, 2011
February 2010
July 2010   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Thyroid Neoplasm
  • Drug: fentanyl citrate
    According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
  • Drug: saline
    According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
  • Placebo Comparator: saline
    control group
    Intervention: Drug: saline
  • Active Comparator: F1 group
    F1 group : fentanyl 1 mcg/kg
    Intervention: Drug: fentanyl citrate
  • Active Comparator: F1.5 group
    F1.5 group : fentanyl 1.5 mcg/kg
    Intervention: Drug: fentanyl citrate
  • Active Comparator: F2 group
    F2 group : fentanyl 2 mcg/kg
    Intervention: Drug: fentanyl citrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
  • ASA I-II.
  • 20-59 years old.
  • female only.

Exclusion Criteria:

  • signs of difficult intubation.
  • risks for perioperative pulmonary aspiration.
  • history of chronic respiratory disease.
  • recent upper respiratory track infection.
  • previous and recent smoking history
Female
20 Years to 59 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01308320
4-2009-0111
No
Jeong-Rim Lee / Assistant Professor, Severance Hospital, Department of Anesthesiology and Pain Medicine in Yonsei University College of Medicine
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP