The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation
This study has been completed.
Sponsor:
Seoul National University Hospital
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
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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 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 June 18, 2013