Comparison of the Effect Site Concentration of Remifentanil for Preventing Cough During Emergence Between Male and Female Patients With Thyroidectomy - Full Text View

Purpose

The clinical studies demonstrate more powerful analgesic effect among female to both μ- and κ-opioid agonist (Fillingim et al. 2004). The antitussive effect of opioid is mediated predominantly by μ-, κ-opioid receptors (Kamei J. 1996). Therefore, the investigators hypothesized that there are sex differences in the antitussive responses to opioid.

It has been reported that target-controlled infusion (TCI) of remifentanil can reduce cough against endotracheal tube during emergence from general anesthesia. Some studies, reporting the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in different sex and surgeries (B. Lee et al. 2009, E.M.Choi et al. 2012), showed differences in EC50 and EC95.

The purpose of this study was to find out EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during emergence in each sex and to evaluate whether there were sex differences in EC50 and EC95 of remifentanil in effect-site TCI or not.

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


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

Resource links provided by NLM:

MedlinePlus related topics: 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: 20 minutes after sevoflurane off ] [ Designated as safety issue: No ]
The cough was defined as a sudden contraction of the abdomen. The level of cough was assessed and recorded by the following cough grading system: Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 sec with moderate severity; Grade 3, severe, persistent cough for more than 5 sec.

The patients will be followed from Sevolurane off to being transported to PACU.


Enrollment:	46
Study Start Date:	August 2011
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Female group Female gender patients undergoing thyroidectomy	Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients. Other Name: remifentanil Ce, Ultiva Ce
Active Comparator: Male group Male gender patients undergoing thyroidectomy	Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients. Other Name: remifentanil Ce, Ultiva Ce

Arms

Assigned Interventions

Experimental: Female group

Female gender patients undergoing thyroidectomy

Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence

Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients.

Other Name: remifentanil Ce, Ultiva Ce

Active Comparator: Male group

Male gender patients undergoing thyroidectomy

Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence

Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients.

Other Name: remifentanil Ce, Ultiva Ce

Eligibility


Ages Eligible for Study:	25 Years to 46 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

aged 20-46
ASA classification I~II
patients undergoing thyroidectomy

Exclusion Criteria:

patient who has signs of a difficult airway
patient who has smoking history
patient who has upper respiratory infection or sore throat in the previous two weeks
patient who has hypertension, DM
female patients who were pregnant, breast-feeding or menopausal

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01614535

Locations


Korea, Republic of
Department of Anesthesiology and Pain Medicine
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

Investigators


Principal Investigator:	Wyun Kon Park, MD	Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine

More Information

No publications provided


Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01614535 History of Changes
Other Study ID Numbers:	4-2011-0356
Study First Received:	June 3, 2012
Last Updated:	June 7, 2012
Health Authority:	Korea: Food and Drug Administration

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 March 03, 2015