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

• ClinicalTrials.gov Identifier: NCT01614535
• Recruitment Status: Completed
• First Posted: June 8, 2012
• Last Update Posted: June 8, 2012
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Patients Undergoing Thyroidectomy	Drug: up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: August 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. occurrence of cough [ Time Frame: 20 minutes after sevoflurane off ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 46 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01614535
• Other Study ID Numbers: 4-2011-0356
• First Posted: June 8, 2012
• Last Update Posted: June 8, 2012
• Last Verified: June 2012

Additional relevant MeSH terms:

Remifentanil; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents