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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308320
First Posted: March 4, 2011
Last Update Posted: March 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  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
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 59 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 3, 2011
First Posted: March 4, 2011
Last Update Posted: March 4, 2011
Last Verified: March 2011

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


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