- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351285
Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)
June 1, 2013 updated by: Yonsei University
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Sevo group
undergoing sevoflurane-remifentanil anesthesia
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From the completion of surgery to 5minute after extubation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ACTUAL)
October 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
May 4, 2011
First Submitted That Met QC Criteria
May 9, 2011
First Posted (ESTIMATE)
May 10, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 4, 2013
Last Update Submitted That Met QC Criteria
June 1, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2011-0019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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