search
Back to results

The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

Primary Purpose

Brain Tumor, AVM, ICH

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
remifentanil
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Brain Tumor

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

neurosurgery with fixation

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2011
Last Updated
August 15, 2012
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01489137
Brief Title
The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation
Official Title
The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation in the Patients Undergoing Neurosurgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, AVM, ICH

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
neurosurgery with fixation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
remifentanil
Other Intervention Name(s)
Biased coin design up-and-down method.
Intervention Description
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.
Primary Outcome Measure Information:
Title
mean arterial blood pressure
Description
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.
Time Frame
peri-fixation periord
Title
heart rate
Description
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.
Time Frame
peri-fixation periord

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29017455
Citation
Lee JM, Bahk JH, Lim YJ, Lee J, Lim L. The EC90 of remifentanil for blunting cardiovascular responses to head fixation for neurosurgery under total intravenous anesthesia with propofol and remifentanil based on bispectral index monitoring: estimation with the biased coin up-and-down sequential method. BMC Anesthesiol. 2017 Oct 10;17(1):136. doi: 10.1186/s12871-017-0426-z.
Results Reference
derived

Learn more about this trial

The EC90 of Remifentanil Blunting Hemodynamic Changes to Head Fixation

We'll reach out to this number within 24 hrs