Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000506291
Ethics application status
Approved
Date submitted
19/12/2017
Date registered
6/04/2018
Date last updated
6/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
In hypertensive patients; effect of induction of anesthesia on cerebral tissue oxygen saturation
Scientific title
In hypertensive patients; effect of induction of anesthesia on cerebral tissue oxygen saturation
Secondary ID [1] 293635 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 305909 0
Condition category
Condition code
Anaesthesiology 305103 305103 0 0
Anaesthetics
Cardiovascular 305104 305104 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The patients ' demographic data will be recorded. 200 patients who will undergo general anaesthesia will be included in the study. Patients will be allocated to two groups with and without hypertension. Patients will be taken to the operating room after they receive their consents and demographic information. As a standard, noninvasive blood pressure, SpO2 and ECG will be monitored. Cerebral oxygenation will be monitored with near-infrared spectroscopy pallets placed on patients' foreheads. Standard general anaesthesia induction will be performed by the patient's anesthesiologist. Heart rate, blood pressure, SpO2, endtidal CO2, and cerebral oxygen saturation will be recorded by the investigator at pre-induction, post-induction, post-intubation and until surgical initiation with intervals of 5 minutes. Patients with hypertension; the duration of the hypertension, the antihypertensive medication used, and the last taken time information received. General anaesthetic drugs applied to the patient will be recorded. Follow-up of the patient will be terminated after initiation of surgery.
Intervention code [1] 299897 0
Early Detection / Screening
Comparator / control treatment
100 patients without hypertension will be taken as a control group. The same steps as the hypertensive group will be included in the study.
Control group
Active

Outcomes
Primary outcome [1] 304273 0
Change of cerebral tissue oxygen saturation of patients with hypotension after anaesthesia induction. Calculated using low frequency haemoglobin oscillations measured using near infrared spectroscopy
Timepoint [1] 304273 0
Before induction, After induction, After intubation, At 5 minutes after induction, At 10 minutes after induction, At 15 minutes after induction (primary outcome).
Secondary outcome [1] 343002 0
Change in blood pressure during anaesthesia induction. We are using an automatic sphygmomanometer
Timepoint [1] 343002 0
Before induction
After induction
After intubation
At 5 minutes after induction
At 10 minutes after induction
At 15 minutes after induction

Eligibility
Key inclusion criteria
over 18 years
ASA I-III
Those who undergo general anesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years old
ASA IV-VI
Emergency Patients
Hemodynamically unstable patients
Pregnant women
Those with cerebrovascular disease
Cranial Surgery
Carotid stenosis and carotid operation

Study design
Purpose
Screening
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/01/2018
Date of last participant enrolment
Anticipated
31/05/2018
Actual
Date of last data collection
Anticipated
31/05/2018
Actual
Sample size
Target
200
Accrual to date
60
Final
Recruitment outside Australia
Country [1] 9447 0
Turkey
State/province [1] 9447 0
ANKARA

Funding & Sponsors
Funding source category [1] 298255 0
Self funded/Unfunded
Name [1] 298255 0
YASIN TASKALDIRAN
Country [1] 298255 0
Turkey
Funding source category [2] 298257 0
Self funded/Unfunded
Name [2] 298257 0
ÖZLEM SEN
Country [2] 298257 0
Turkey
Primary sponsor type
Individual
Name
YASIN TASKALDIRAN
Address
Dr.Abdurrahman Yurtaslan Ankara Onkology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Country
Turkey
Secondary sponsor category [1] 297367 0
Individual
Name [1] 297367 0
OZLEM SEN
Address [1] 297367 0
Dr.Abdurrahman Yurtaslan Ankara Onkology Education and Research Hospital Clinic of Anesthesiology and Reanimation
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Country [1] 297367 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299258 0
Dr.Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital Ethics Committee
Ethics committee address [1] 299258 0
Dr.Abdurrahman Yurtaslan Ankara Onkology Education and Research Hospital
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Ethics committee country [1] 299258 0
Turkey
Date submitted for ethics approval [1] 299258 0
27/11/2017
Approval date [1] 299258 0
05/12/2017
Ethics approval number [1] 299258 0
2017-12/02

Summary
Brief summary
Hemodynamic changes can be seen during induction of general anaesthesia. Especially hypotension occurs. Althought there are several factors in determining the perfusion of cerebral tissue, the most important one is mean arterial blood pressure. In a study performed, cerebral tissue oxygen saturation was evaluated after induction of anaesthesia and there was no change in cerebral tissue oxygen saturation despite hypotension in patients. Cerebral tissue perfusion can be maintained at a constant current due to autoregulation against changes in mean arterial pressure. However, cerebral tissue perfusion in hypertensive patients is becoming more susceptible to changes in mean arterial blood pressure. The mean arterial pressure must be higher in order to maintain the cerebral tissue perfusion constant.
In the light of this information, we also aim to investigate the hemodynamic changes that may occur during anaesthesia induction, the cerebral tissue oxygen saturation in hypertensive patients and hence the effect on cerebral tissue perfusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79818 0
Dr YASIN TASKALDIRAN
Address 79818 0
Dr. Abdurrahman Yurtaslan Oncology Training Education Hospital Clinic of Anesthesiology and Reanimation
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Country 79818 0
Turkey
Phone 79818 0
+905342525487
Fax 79818 0
Email 79818 0
[email protected]
Contact person for public queries
Name 79819 0
Dr OZLEM SEN
Address 79819 0
Dr. Abdurrahman Yurtaslan Oncology Training Education Hospital Clinic of Anesthesiology and Reanimation
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Country 79819 0
Turkey
Phone 79819 0
+905063591751
Fax 79819 0
Email 79819 0
[email protected]
Contact person for scientific queries
Name 79820 0
Dr YASIN TASKALDIRAN
Address 79820 0
Dr. Abdurrahman Yurtaslan Oncology Training Education Hospital Clinic of Anesthesiology and Reanimation
Mehmet Akif Ersoy Neighborhood /13. Street/06200 Yenimahalle/Ankara
Country 79820 0
Turkey
Phone 79820 0
+905342525487
Fax 79820 0
Email 79820 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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