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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01308320
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 4
• Duration (Months): 4.9
• Patients Per Site Per Month: 8.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Neoplasm	Drug: fentanyl citrate; Drug: saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: saline control group	Drug: saline; According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
Active Comparator: F1 group F1 group : fentanyl 1 mcg/kg	Drug: fentanyl citrate; According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
Active Comparator: F1.5 group F1.5 group : fentanyl 1.5 mcg/kg	Drug: fentanyl citrate; According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
Active Comparator: F2 group F2 group : fentanyl 2 mcg/kg	Drug: fentanyl citrate; According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 59 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Nishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9.
• Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66.

• ClinicalTrials.gov Identifier: NCT01308320
• Other Study ID Numbers: 4-2009-0111
• First Posted: Mar 4, 2011
• Last Update Posted: Mar 4, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Thyroid Neoplasms; Fentanyl

Study Results

No Results Posted as of Mar 4, 2011