The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation
This study has been completed.
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
First received: December 5, 2011
Last updated: August 15, 2012
Last verified: August 2012
The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.
||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation in the Patients Undergoing Neurosurgery
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.
| Study Start Date:
| Primary Completion Date:
||February 2012 (Final data collection date for primary outcome measure)
Experimental: neurosurgery with fixation
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.
|Ages Eligible for Study:
||20 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- patients undergoing neurosurgery that require head fixation with mayfield head holder
- patients who agree to our study
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01489137
|Seoul National University Hospital
|Seoul, Korea, Republic of, 110-744 |
Seoul National University Hospital
No publications provided
||Jae-Hyon Bahk, MD, PhD, professor, Seoul National University Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 5, 2011
||August 15, 2012
||Korea: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2015
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents