Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000580370
Ethics application status
Approved
Date submitted
1/04/2017
Date registered
24/04/2017
Date last updated
1/04/2019
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cerebral blood flow changes during different entropy value targeted (entropy value 30-40 versus entropy value 50- 60 ) anesthesia induction with propofol in patients undergoing supratentorial tumor surgery.
Scientific title
Cerebral blood flow changes during different entropy value targeted anesthesia induction with propofol in patients undergoing supratentorial tumor surgery: A prospective, randomized Clinical Trial.
Secondary ID [1] 291600 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with supratentorial tumor, 302711 0
anesthetics effect on cerebral blood flow 302712 0
Condition category
Condition code
Cancer 302231 302231 0 0
Brain
Anaesthesiology 302232 302232 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have two study group depend on propofol dose that used at anesthesia induction. In all groups, we will use the same anesthetic agent as fentanyl, propofol, and rocuronium.
Arm 1 (Group L, low state entropy value target group ): For anesthetic induction, firstly 1 mcg/kg fentanyl will be administered as a bolus intravenously. Then 0.04 % propofol ( 800 mg PROPOFOL %1 Fresenius in 100 ml 0.9% isotonic ) infusion will be given intravenously at the rate of 50 mg/kg/h (10 seconds waited for every 20 seconds infusion period) by infusion pump until state entropy value reaches between 40 to 30 After adequate hypnosis, 0.6mg/kg rocuronium bromide will be administered as a bolus.
Arm 2 (Group H highe state entropy value target group ) : For anesthetic induction, firstly 1 mcg/kg fentanyl will be administered as a bolus intravenously. Then 0.04 % propofol ( 800 mg PROPOFOL %1 Fresenius in 100 ml 0.9% isotonic ) infusion will be given intravenously at the rate of 50 mg/kg/h (10 seconds waited for every 20 seconds infusion period) by infusion pump until state entropy value reaches between 60 to 50 After adequate hypnosis, 0.6mg/kg rocuronium bromide will be administered as a bolus.
Intervention code [1] 297669 0
Treatment: Drugs
Comparator / control treatment
None control group. We will compare between targeted entropy value of 30-40 and 50-60 for propofol administration.effects on middle cerebral artery blood flow .
Control group
Dose comparison

Outcomes
Primary outcome [1] 301643 0
Mean blood flow velocity values of bilateral middle cerebral artery which measured by transcranial doppler sonography (DWL Elektronische Systeme GmbH, Sipplingen, Germany ). All doppler measurements will be performed by the same experienced neurologist. The middle cerebral artery will be insonated at 50–55 mm depth through the temporal window by the 2 MHz probe of transcranial doppler sonography device.
Timepoint [1] 301643 0
Before anesthesia induction, after anesthesia induction, immediately after endotracheal intubation, 1 minute later endotracheal intubation, 3 minutes later endotracheal intubation and 5 minutes later endotracheal intubation.
Secondary outcome [1] 333419 0
Systolic blood flow velocity value of bilateral middle cerebral artery which measured by transcranial doppler sonography (DWL Elektronische Systeme GmbH, Sipplingen, Germany ). All doppler measurements will be performed by the same experienced neurologist. The middle cerebral artery will be insonated at 50–55 mm depth through the temporal window by the 2 MHz probe of transcranial doppler sonography device.
Timepoint [1] 333419 0
Before anesthesia induction, after anesthesia induction, immediately after endotracheal intubation, 1 minute later endotracheal intubation, 3 minutes later endotracheal intubation and 5 minutes later endotracheal intubation.
Secondary outcome [2] 333672 0
Diastolic blood flow velocity value of bilateral middle cerebral artery which measured by transcranial doppler sonography (DWL Elektronische Systeme GmbH, Sipplingen, Germany ). All doppler measurements will be performed by the same experienced neurologist. The middle cerebral artery will be insonated at 50–55 mm depth through the temporal window by the 2 MHz probe of transcranial doppler sonography device.
Timepoint [2] 333672 0
Before anesthesia induction, after anesthesia induction, immediately after endotracheal intubation, 1 minute later endotracheal intubation, 3 minutes later endotracheal intubation and 5 minutes later endotracheal intubation.
Secondary outcome [3] 333673 0
Mean arterial pressure that measured with invasive radial artery cannulation by patient monitor (CARESCAPE Monitor B850; GE Healthcare, Helsinki, Finland ).
Timepoint [3] 333673 0
Before anesthesia induction, after anesthesia induction, immediately after endotracheal intubation, 1 minute later endotracheal intubation, 3 minutes later endotracheal intubation and 5 minutes later endotracheal intubation.

Eligibility
Key inclusion criteria
1- Patients undergoing elective supratentorial tumor surgery.
2- Patients need invasive artery monitorization.
3- Patients with ASA grade I-II.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Patients with pregnancy
2- Patients with morbid obesity (body mass index < 40)
3- Patients with a history of cerebral, cardiac or systemic vascular disorders.
4- Patients with serious systemic illness such as heart failure, arrhythmia, valvular heart disease, pulmonary hypertension, uncontrolled hypertension, insulin-dependent diabetes, pulmonary diseases (e.g., COPD, asthma, bronchiectasis), kidney disease, or endocrine diseases;
5-Patients with a history of previous cranial surgery or brain trauma.

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
15/05/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
Actual
16/10/2017
Date of last data collection
Anticipated
Actual
16/10/2017
Sample size
Target
40
Accrual to date
Final
15
Recruitment outside Australia
Country [1] 8773 0
Turkey
State/province [1] 8773 0

Funding & Sponsors
Funding source category [1] 296087 0
Self funded/Unfunded
Name [1] 296087 0
achmet ali
Country [1] 296087 0
Turkey
Primary sponsor type
Individual
Name
achmet ali
Address
istanbul medical faculty,Department of Anesthesiology ,turgut ozal cad. no: 12, 34104 istanbul
Country
Turkey
Secondary sponsor category [1] 294983 0
None
Name [1] 294983 0
Address [1] 294983 0
Country [1] 294983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297344 0
Ethics Committee of Istanbul University, Istanbul Medical Faculty, Istanbul, Turkey
Ethics committee address [1] 297344 0
Ethics committee country [1] 297344 0
Turkey
Date submitted for ethics approval [1] 297344 0
07/04/2017
Approval date [1] 297344 0
11/04/2017
Ethics approval number [1] 297344 0
2017/382

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73762 0
Dr achmet ali
Address 73762 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 73762 0
Turkey
Phone 73762 0
+905424878264
Fax 73762 0
Email 73762 0
[email protected]
Contact person for public queries
Name 73763 0
achmet ali
Address 73763 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 73763 0
Turkey
Phone 73763 0
+905424878264
Fax 73763 0
Email 73763 0
[email protected]
Contact person for scientific queries
Name 73764 0
achmet ali
Address 73764 0
istanbul medical faculty, Department of Anesthesiology,turgut ozal cad. no:12 34104 istanbul,turkey
Country 73764 0
Turkey
Phone 73764 0
+905424878264
Fax 73764 0
Email 73764 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.