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

NCT01735019 | Completed

• 1 other identifier: 4-2012-0350
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypophysectomy

Keywords

EC95, effective concentration in 95% of subjects

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

group 1

EXPERIMENTAL

administration of remifentanil with target-controlled infusion (TCI) system at a given concentration during anesthetic emergence

Drug: Administration of remifentanil with TCI system

Interventions

Administration of remifentanil with TCI system DRUG

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.

group 1

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled to undergo hypophysectomy with transsphenoidal approach
• American Society of Anesthesiologists physical status I or II
• more than 20 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Seoul, 120-752, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2012
• First Posted: November 28, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 18, 2013

Record last verified: 2012-11

Locations

KR (1)