Hypophysectomy
Conditions
Keywords
EC95, effective concentration in 95% of subjects
Brief summary
In patients undergoing hypophysectomy through transsphenoidal approach, preventing cough during anesthetic emergence is important to avoid hemorrhage and cerebrospinal fluid leakage. Previous reports demonstrated that administration of remifentanil during anesthetic emergence could reduce the incidence and severity of cough during anesthetic emergence. Therefore, the objective of this study is to determine EC95 of remifentanil for preventing cough during anesthetic emergence in patients undergoing hypophysectomy with transsphenoidal approach.
Interventions
DRUGAdministration of remifentanil with TCI system
A given effect site concentration of remifentanil would be administered to subjects using TCI system. According to biased coin design, the given concentration of remifentanil is determined according to success or failure of just previously enrolled patient. If the former patient did not cough during anesthetic emergence at a given concentration (success), the next patient will be randomly allocated into the same concentration of remifentanil with 18/19 of probability or the lower concentration of remifentanil by 0.4 ng/ml with 1/19 of probability. If the former patient coughed during anesthetic emergence (failure), the next will be automatically allocated into the higher concentration of remifentanil by 0.4 ng/ml.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* scheduled to undergo hypophysectomy with transsphenoidal approach * American Society of Anesthesiologists physical status I or II * more than 20 years old
Exclusion criteria
* acute or chronic respiratory disease * uncontrolled hypertension * taking sedatives or anti-tussive * gastro-esophageal reflux * pregnant or breast feeding * patients who cannot understand statements for subjects or this study itself
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The occurrence of cough during anesthetic emergence | 5 min after extubation | At a given effect-site concentration of remifentanil, if cough does not occur during anesthetic emergence, it would be considered as a success. On the other hand, if cough occurs during anesthetic emergence, it would be considered as a failure. |
Countries
South Korea
Outcome results
None listed