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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01735019
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : September 18, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypophysectomy Drug: Administration of remifentanil with TCI system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01735019

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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University Identifier: NCT01735019     History of Changes
Other Study ID Numbers: 4-2012-0350
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: November 2012

Keywords provided by Yonsei University:
EC95, effective concentration in 95% of subjects

Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents