Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000471189
Ethics application status
Approved
Date submitted
18/03/2019
Date registered
21/03/2019
Date last updated
4/06/2019
Date data sharing statement initially provided
21/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of the effects of arterial blood pressure and cardiac output based hemodynamic management on cognitive function in elderly patients undergoing spinal surgery: A Randomized Clinical Trial.
Scientific title
Comparison of the effects of arterial blood pressure and cardiac output based hemodynamic management on cognitive function in patients over 60 years old undergoing spinal surgery: A Randomized Clinical Trial.
Secondary ID [1] 297594 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal surgery 311853 0
Condition category
Condition code
Anaesthesiology 310449 310449 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will make cardiac output and stroke volume measurement during surgery with FloTrac pulse conture cardiac output sensor ( Edwards Lifesciences, Irvine, CA, USA) using right or left radial artery cannulation. Hemodynamic management will be made according to Cardiac index value. We will aim to maintain Cardiac index value within ± 20% of the baseline value that measured before anesthesia induction.
Intervention is the measurement of cardiac index and management of hemodynamics of patients according to the cardiac index value. The intervention will start before surgery and will continue until surgery finished. The intervention will be made by one of the researchers.
Treatment of inadequate cardiac index will be included infusion of crystalloid solution, administration of bolus ephedrine sulfate (5mg) and noradrenaline infusion with start dose of 0.02 mcg/kg/min (if the infusion of crystalloid and administration of ephedrine will be insufficient)
Intervention code [1] 313828 0
Treatment: Other
Comparator / control treatment
We will make Invasive arterial pressure measurement during surgery using right or left radial artery cannulation. Hemodynamic management will be made according to mean arterial pressure and systolic arterial pressure values. We will aim to maintain mean arterial pressure and systolic arterial pressure values within ± 20% of the baseline values that measured before anesthesia induction.
The difference from the intervention group is that we only measure arterial pressure not cardiac index and we will make hemodynamic management according to mean arterial pressure in control group.
Treatment of inadequate mean arterial pressure will be included infusion of crystalloid solution, administration of bolus ephedrine sulfate (5mg) and noradrenaline infusion with start dose of 0.02 mcg/kg/min (if the infusion of crystalloid and administration of ephedrine will be insufficient)
Control group
Active

Outcomes
Primary outcome [1] 319316 0
Montreal Cognitive Assessment (cognitive function test) test will apply patients one day before surgery and seven days after surgery.
Timepoint [1] 319316 0
one day before surgery
seven day after surgery
Secondary outcome [1] 367721 0
Comparison of the cerebral oxygen saturation during surgery between groups as assessed by INVOS™ 5100C Cerebral/Somatic Oximeter.
Timepoint [1] 367721 0
during surgery

Eligibility
Key inclusion criteria
1-age equal or over 60 years
2-patients who undergo spinal surgery
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-not have epilepsy
2-not undergo brain surgery before
3-not have carotid stenosis
4-not have hydrocephalus

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2019
Actual
15/04/2019
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
8/07/2019
Actual
Sample size
Target
60
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 21324 0
Turkey
State/province [1] 21324 0
istanbul

Funding & Sponsors
Funding source category [1] 302143 0
University
Name [1] 302143 0
Istanbul medical faculty
Country [1] 302143 0
Turkey
Primary sponsor type
University
Name
Istanbul medical faculty
Address
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country
Turkey
Secondary sponsor category [1] 301978 0
None
Name [1] 301978 0
Address [1] 301978 0
Country [1] 301978 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302822 0
Ethics Committee of Istanbul Medical Faculty
Ethics committee address [1] 302822 0
Ethics Committee of Istanbul Medical Faculty, turgut ozal cad. no: 12, 34104 istanbul
Ethics committee country [1] 302822 0
Turkey
Date submitted for ethics approval [1] 302822 0
12/03/2019
Approval date [1] 302822 0
15/03/2019
Ethics approval number [1] 302822 0
2019/361

Summary
Brief summary
We hypothesize that cardiac index based hemodynamic management can provide better postoperative cognitive function compared with arterial pressure-based hemodynamic management in elderly patients. Also, we expect cerebral oximetry desaturation will be less in the cardiac index group.
Montreal Cognitive Assessment (cognitive function test) test will apply patients one day before surgery and seven days after surgery. Patients will be randomized to either a Cardiac index group (We will aim to maintain Cardiac index value within ± 20% of the baseline value that measured before anesthesia induction) or an arterial pressure group (Hemodynamic management will be made according to mean arterial pressure and systolic arterial pressure values. We will aim to maintain mean arterial pressure and systolic arterial pressure values within ± 20% of the baseline values that measured before anesthesia induction).
In both group, entropy (depth of anesthesia) and cerebral oximeter will be measured. Anesthesia level will be adjust according to state entropy value. Target value is 40 to 60.
In both groups, researchers who follow patients and record hemodynamic data will be blind to cerebral oximetry monitorization. Cerebral oximetry will be recorded by another researcher.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91514 0
A/Prof achmet ali
Address 91514 0
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country 91514 0
Turkey
Phone 91514 0
+902124142000
Fax 91514 0
Email 91514 0
[email protected]
Contact person for public queries
Name 91515 0
A/Prof achmet ali
Address 91515 0
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country 91515 0
Turkey
Phone 91515 0
+902124142000
Fax 91515 0
Email 91515 0
[email protected]
Contact person for scientific queries
Name 91516 0
A/Prof achmet ali
Address 91516 0
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country 91516 0
Turkey
Phone 91516 0
+902124142000
Fax 91516 0
Email 91516 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.