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

September 17, 2013 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
administration of remifentanil with target-controlled infusion (TCI) system at a given concentration during anesthetic emergence
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The occurrence of cough during anesthetic emergence
Time Frame: 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.
5 min after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 18, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 28, 2012

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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