ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01351285
Recruitment Status : Completed
First Posted : May 10, 2011
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Female Patients Undergoing Thyroidectomy Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough Not Applicable

Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Cough
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. occurrence of cough [ Time Frame: From the completion of surgery to 5minute after extubation ]
    We will assess the occurrence of cough during emergence from general anesthesia in female patients undergoing target controlled infusion of remifentanil at predetemined concentration.


Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 60 Years   (Adult)
Sexes 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
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01351285


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01351285     History of Changes
Other Study ID Numbers: 4-2011-0019
First Posted: May 10, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Remifentanil
Sevoflurane
Desflurane
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Platelet Aggregation Inhibitors
Anesthetics, Inhalation