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

This study is currently recruiting participants.

Verified November 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01735019

First received: November 18, 2012

Last updated: November 23, 2012

Last verified: November 2012

History of Changes

Purpose

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	Intervention
Hypophysectomy	Drug: Administration of remifentanil with TCI system

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

Resource links provided by NLM:

MedlinePlus related topics: Cough

Drug Information available for: Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

The occurrence of cough during anesthetic emergence [ Time Frame: 5 min after extubation ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	40
Study Start Date:	November 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01735019

Contacts

Contact: Seung Ho Choi, MD

82-2-2227-3833

CSHO99@yuhs.ac

Locations

Korea, Republic of
Severance Hospital	Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jae Hoon Lee, MD 82-2-2227-3972 NEOGENS@yuhs.ac
Sub-Investigator: Jae Hoon Lee, MD

Sponsors and Collaborators

Yonsei University

More Information

No publications provided

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01735019 History of Changes
Other Study ID Numbers:	4-2012-0350
Study First Received:	November 18, 2012
Last Updated:	November 23, 2012
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Yonsei University:

EC95, effective concentration in 95% of subjects

Additional relevant MeSH terms:

Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 23, 2013

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