The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489137
• Other study ID #: JHBahk_fixation_remifentanil
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: August 15, 2012
• Start date: November 2011

Study information

• Verified date: August 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• AVM
• Brain Tumor
• ICH

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean arterial blood pressure	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.	peri-fixation periord	No
Primary	heart rate	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.	peri-fixation periord	No