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

Not Applicable

Completed

• Conditions: Hypophysectomy
• Interventions: Drug: Administration of remifentanil with TCI system

• Registration Number: NCT01735019
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2012-11
• Study Start: 2012-11
• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-28
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-09-17
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
group 1	Administration of remifentanil with TCI system	administration of remifentanil with target-controlled infusion (TCI) system at a given concentration during anesthetic emergence

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of