The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

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

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Key information

Conditions

Brain Tumor AVM Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms ICH Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remifentanil

Drug

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 names: Biased coin design up-and-down method.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
First posted: Dec 9, 2011
Registry last updated: Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed