The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01489137
First received: December 5, 2011
Last updated: August 15, 2012
Last verified: August 2012
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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 Seoul National University Hospital:

Primary Outcome Measures:
  • mean arterial blood pressure [ Time Frame: peri-fixation periord ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489137

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

No publications provided

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
Study First Received: December 5, 2011
Last Updated: August 15, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 April 16, 2014