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

NCT ID: NCT01614535

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

Conditions

Patients Undergoing Thyroidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Female group

Female gender patients undergoing thyroidectomy

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Male group

Male gender patients undergoing thyroidectomy

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

remifentanil Ce, Ultiva Ce

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 46 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wyun Kon Park, MD

Role: PRINCIPAL_INVESTIGATOR

Yonsei University College of Medicine, Department of Anesthesiology and Pain Medicine

Locations

Department of Anesthesiology and Pain Medicine

Seoul, Seoul, South Korea

Countries

South Korea

Other Identifiers

4-2011-0356

Identifier Type: -

Identifier Source: org_study_id