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

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:

MedlinePlus related topics: Anesthesia Cough

Drug Information available for: Remifentanil hydrochloride

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on February 27, 2015