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

Thyroid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308320
• Other study ID #: 4-2009-0111
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2011
• Last updated: March 3, 2011
• Start date: February 2010
• Est. completion date: July 2010

Study information

• Verified date: March 2011
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 59 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

Drug:
• fentanyl citrate
According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
• saline
According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. — View Citation

Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. — View Citation