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The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01489137
First Posted: December 9, 2011
Last Update Posted: August 17, 2012
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.
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
  Purpose
The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.

Condition Intervention
Brain Tumor AVM ICH Drug: remifentanil

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation in the Patients Undergoing Neurosurgery

Resource links provided by NLM:


Further study details as provided by Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital:

Primary Outcome Measures:
  • mean arterial blood pressure [ Time Frame: peri-fixation periord ]
    mean arterial blood pressure will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation.

  • heart rate [ Time Frame: peri-fixation periord ]
    heart rate will be recorded at 2 minutes before fixation, 1 minute before fixation, highest value during immediately post-fixation periord, 1 minute after fixation, 2 minutes after fixation, 3 minutes after fixation, 4 minutes after fixation and 5 minutes after fixation.


Enrollment: 50
Study Start Date: November 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neurosurgery with fixation Drug: remifentanil

According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during head fixation. And, For this allocation of dose of remifentanil the investigators use biased coin design up-and-down method.

For the first patient, the dose of remifentanil would be fixed at 5.5ng/ml which we predict as EC90. And, step size of dose is 0.5ng/ml.

Other Name: Biased coin design up-and-down method.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing neurosurgery that require head fixation with mayfield head holder
  • patients who agree to our study

Exclusion Criteria:

  • patients who don't agree to our study
  • BMI<16.0 or BMI>30
  • cardiovascular disease, pulmonary disease, renal disease
  • alcoholic abuser or drug abuser
  • patients who takes any drug having an influence on cardiovascular system or sympathetic nervous system
  • any use of local anesthetics or drugs which have an influence on cardiovascular system from beginning of induction to peri-fixation period
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01489137


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Jae-Hyon Bahk, MD, PhD, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01489137     History of Changes
Other Study ID Numbers: JHBahk_fixation_remifentanil
First Submitted: December 5, 2011
First Posted: December 9, 2011
Last Update Posted: August 17, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics