Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedMarch 4, 2011
March 1, 2011
5 months
March 3, 2011
March 3, 2011
Conditions
Study Arms (4)
saline
PLACEBO COMPARATORcontrol group
F1 group
ACTIVE COMPARATORF1 group : fentanyl 1 mcg/kg
F1.5 group
ACTIVE COMPARATORF1.5 group : fentanyl 1.5 mcg/kg
F2 group
ACTIVE COMPARATORF2 group : fentanyl 2 mcg/kg
Interventions
According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
Eligibility Criteria
You may qualify if:
- the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm.
- ASA I-II.
- years old.
- female only.
You may not qualify if:
- signs of difficult intubation.
- risks for perioperative pulmonary aspiration.
- history of chronic respiratory disease.
- recent upper respiratory track infection.
- previous and recent smoking history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
Related Publications (2)
Tagaito Y, Isono S, Nishino T. Upper airway reflexes during a combination of propofol and fentanyl anesthesia. Anesthesiology. 1998 Jun;88(6):1459-66. doi: 10.1097/00000542-199806000-00007.
PMID: 9637637BACKGROUNDNishina K, Mikawa K, Maekawa N, Obara H. Fentanyl attenuates cardiovascular responses to tracheal extubation. Acta Anaesthesiol Scand. 1995 Jan;39(1):85-9. doi: 10.1111/j.1399-6576.1995.tb05597.x.
PMID: 7725888BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 4, 2011
Study Start
February 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
March 4, 2011
Record last verified: 2011-03