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

Tracking Information
First Received Date ^ICMJE	March 3, 2011
Last Updated Date	March 3, 2011
Start Date ^ICMJE	February 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Official Title ^ICMJE	Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Condition ^ICMJE	Thyroid Neoplasm
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	42
Completion Date	July 2010
Primary Completion Date	July 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	20 Years to 59 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01308320
Other Study ID Numbers ^ICMJE	4-2009-0111
Has Data Monitoring Committee	No
Responsible Party	Jeong-Rim Lee / Assistant Professor, Severance Hospital, Department of Anesthesiology and Pain Medicine in Yonsei University College of Medicine
Study Sponsor ^ICMJE	Yonsei University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Yonsei University
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top