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The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation in the Patients Undergoing Neurosurgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01489137
Enrollment
50
Registered
2011-12-09
Start date
2011-11-30
Completion date
Unknown
Last updated
2012-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AVM, Brain Tumor, ICH

Brief summary

The purpose of this study is to estimate the EC90 of remifentanil blunting hemodynamic changes to head fixation in the patients undergoing neurosurgery.

Interventions

DRUGremifentanil

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mean arterial blood pressureperi-fixation periordmean 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 rateperi-fixation periordheart 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026