Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246, Germany
NCT Number: NCT04978558
Postoperative neurocognitive disorders (NCD) are of high priority in perioperative management. The risk of suffering from NCD after surgery may be increased due to perioperative impairment of cerebrovascular autoregulation and thereby inadequate cerebral perfusion. Cerebrovascular autoregulation refers to the ability of cerebral arterioles to ensure constant cerebral blood flow independently of fluctuations in systemic blood pressure.
Cerebrovascular autoregulation can be measured based on mean arterial pressure (MAP) and a surrogate for cerebral blood flow using the correlation method. Until today, measurement of cerebral blood flow velocity assessed with transcranial Doppler sonography (TCD) is most commonly used as a non-invasive surrogate for cerebral blood flow. Alternatively, cerebral oxygenation measured with near-infrared spectroscopy (NIRS) can be used as another surrogate.
The study includes three substudies:
1. To compare NIRS and TCD for the assessment of perioperative cerebrovascular autoregulation in patients undergoing major non-cardiac surgery with an increased risk of bleeding. 2. To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia. 3. To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.
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Notify Me18 year–99 year
All sexes
Observational
Hamburg, 20246, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous monitoring of MAP, cerebral oxygenation, and cerebral blood flow velocity before, during, and after surgery to calculate two cerebrovascular autoregulation indices Cox and Mx.
Time frame: up to 4 hours during surgery
calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography
Time frame: up to 2 hours after surgery
MAP at lowest cerebral autoregulation index COx
Time frame: days 1 to 4 after surgery (delirium), day 7 after surgery or at day of discharge from hospital (NCD)
screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function
Time frame: up to 4 hours during surgery
MAP at lowest cerebral autoregulation index (Mx)
Time frame: days 1 to 4 after surgery
screening for postoperative delirium
Time frame: day 7 after surgery or at day of discharge from hospital
neuropsychological assessment
Time frame: date of discharge from hospital (up to 30 days)
duration of hospital stay (in days) between surgery and discharge
Time frame: date of discharge from ICU (up to 30 days)
duration of intensive care unit stay (in days) between surgery and discharge
Time frame: 3 months after surgery
survival status three months after surgery
Universitätsklinikum Hamburg-Eppendorf
Other
Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography
Acronym: SONICA
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