The Effect of Controlled Hypotension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAnkara Etlik City Hospital
About this trial
Controlled hypotension is currently used in spinal surgery to reduce bleeding at the surgical site, improve the surgeon's visibility, and decrease intraoperative blood loss. Although controlled hypotension is considered a beneficial method from a surgical perspective, it is important to be cautious about its side effects. One such side effect is cerebral perfusion insufficiency, which can be managed by monitoring cerebral circulation through regional cerebral oxygen saturation (rSO2).
The aim of this study is to compare the effects of controlled hypotension at specific MAP ranges on cerebral oxygen saturation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years
ASA I-III risk group
BMI between 18-40
Baseline blood pressure below 140/90 mmHg
Disqualifiers
Below 18 or above 65 years old
Advanced comorbidities
ASA IV or higher
Baseline blood pressure above 140/90 mmHg
Trial design
Design model
Parallel
Treatments tested in this trial
MAP 55-65 mmHg
Other interventionMAP will be maintained between 55-65 mmHg during anesthesia.
MAP 66-75 mmHg
Other interventionMAP will be maintained between 66-75 mmHg during anesthesia.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group MAP 55-65 mmHgOther 1 intervention
Group B: Group MAP 66-75 mmHgOther 1 intervention
Trial outcomes
Primary outcomes
1
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Time frame
5 minutes before induction of anesthesia2
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Time frame
5 minutes after intubation3
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Time frame
5 minutes after positioning prone4
Near infrared spectroscopy (NIRS)
cerebral oxygen saturation
Time frame
1 minutes after first surgical incision is madeSecondary outcomes
1
mini mental test
It is used to evaluate cognitive function.
Time frame
15 minutes before induction of anesthesia2
mini mental test
It is used to evaluate cognitive function.
Time frame
30 minutes after extubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: