Estimating EC95 of Remifentanil for Cough Prevention During Emergence From Total Intravenous Anesthesia With Propofol and Remifentanil in Patients Undergoing Transsphenoidal Hypophysectomy

Hypophysectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735019
• Other study ID #: 4-2012-0350
• Status: Completed
• Phase: N/A
• First received: November 18, 2012
• Last updated: September 17, 2013
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2012
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypophysectomy

Intervention

Drug:
• Administration 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence of cough during anesthetic emergence	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.	5 min after extubation	No