Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01351285
First received: May 4, 2011
Last updated: June 1, 2013
Last verified: June 2013
  Purpose

It has been reported that target-controlled infusion of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. We hypothesized that effective concentration of remifentanil for preventing cough during anesthetic emergence varies depending on the type of main anesthetic agents which is administered with remifentanil during general anesthesia. The purpose of this study is to evaluate the effective concentrations of remifentanil to prevent coughing during emergence from general anesthesia according to main anesthetic agent (sevoflurane, desflurane, and propofol).


Condition Intervention
Female Patients Undergoing Thyroidectomy
Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • occurrence of cough [ Time Frame: From the completion of surgery to 5minute after extubation ] [ Designated as safety issue: No ]
    We will assess the occurrence of cough during emergence from general anesthesia in female patients undergoing target controlled infusion of remifentanil at predetemined concentration.


Enrollment: 78
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sevo group
undergoing sevoflurane-remifentanil anesthesia
Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough
During the emergence from anesthesia, if the patient did not cough, the extubation was defined as smooth emergence and the predetermined effect site concentration of remifentanil for the subsequent patient was decreased by 0.5 ng/mL. Likewise, if the patient coughed anytime around extubation, it was considered a failed smooth emergence and the predetermined effect site concentration for the next patient was increased by 0.5 ng/mL. This up-and-down method was conducted independently for each of the three groups. EC50 of the remifentanil of each group was obtained using the Dixon's method.
Active Comparator: Des group
undergoing desflurane-remifentanil anesthesia
Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough
During the emergence from anesthesia, if the patient did not cough, the extubation was defined as smooth emergence and the predetermined effect site concentration of remifentanil for the subsequent patient was decreased by 0.5 ng/mL. Likewise, if the patient coughed anytime around extubation, it was considered a failed smooth emergence and the predetermined effect site concentration for the next patient was increased by 0.5 ng/mL. This up-and-down method was conducted independently for each of the three groups. EC50 of the remifentanil of each group was obtained using the Dixon's method.
Active Comparator: Pro group
undergoing propofol-remifentanil anesthesia
Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough
During the emergence from anesthesia, if the patient did not cough, the extubation was defined as smooth emergence and the predetermined effect site concentration of remifentanil for the subsequent patient was decreased by 0.5 ng/mL. Likewise, if the patient coughed anytime around extubation, it was considered a failed smooth emergence and the predetermined effect site concentration for the next patient was increased by 0.5 ng/mL. This up-and-down method was conducted independently for each of the three groups. EC50 of the remifentanil of each group was obtained using the Dixon's method.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 20-60
  • ASA classification I~II
  • female patients
  • patients who undergoing thyroidectomy

Exclusion Criteria:

  • Patients with acute or chronic respiratory disease
  • patient who has smoking history
  • patient who has hypertension
  • patient who has esophageal reflux
  • patient who having an expectorant or cough remedy
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351285

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

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01351285     History of Changes
Other Study ID Numbers: 4-2011-0019
Study First Received: May 4, 2011
Last Updated: June 1, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 19, 2014