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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
  Purpose

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 Intervention Phase
Thyroid Neoplasm
 Drug: fentanyl citrate
Drug: saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Enrollment: 42
Study Start Date: February 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 59 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308320

Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Publications:

Responsible Party: Jeong-Rim Lee / Assistant Professor, Severance Hospital, Department of Anesthesiology and Pain Medicine in Yonsei University College of Medicine
ClinicalTrials.gov Identifier: NCT01308320     History of Changes
Other Study ID Numbers: 4-2009-0111
Study First Received: March 3, 2011
Last Updated: March 3, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Anesthetics
Fentanyl
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013