Comparison of Effect-site Concentration of Remifentanil for Preventing Cough Against Endotracheal Tube During Anesthetic Emergence According to Anesthetics (Sevoflurane, Desflurane, and Propofol)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Yonsei University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Yonsei University
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01351285
First received: May 4, 2011
Last updated: May 9, 2011
Last verified: May 2011
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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.
| Estimated Enrollment: | 90 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | April 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351285
Contacts
| Contact: Jeong Rim Lee | 82-2228-2420 | MANYA@yuhs.ac |
Locations
| Korea, Republic of | |
| Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact: Jeong Rim Lee 82-2228-2420 MANY@yuhs.ac | |
| Principal Investigator: Jeong Rim Lee | |
Sponsors and Collaborators
Yonsei University
More Information
No publications provided
| Responsible Party: | Jeong Rim Lee/Assistant professor, Severance Hospital |
| ClinicalTrials.gov Identifier: | NCT01351285 History of Changes |
| Other Study ID Numbers: | 4-2011-0019 |
| Study First Received: | May 4, 2011 |
| Last Updated: | May 9, 2011 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Anesthetics Desflurane Sevoflurane Remifentanil Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Inhalation |
Anesthetics, General Platelet Aggregation Inhibitors Hematologic Agents Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Hypnotics and Sedatives Anesthetics, Intravenous |
ClinicalTrials.gov processed this record on May 21, 2013