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NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04978558
Acronym
SONICA
Enrollment
509
Registered
2021-07-27
Start date
2021-08-09
Completion date
2024-09-19
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Circulation

Keywords

postoperative neurocognitive disorders, postoperative delirium, near-infrared spectroscopy, transcranial Doppler sonography, non-cardiac surgery

Brief summary

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.

Interventions

OTHERContinuous assessment of cerebrovascular autoregulation with NIRS and TCD

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.

Sponsors

Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Elective surgery with a minimum duration of 120 minutes * General anesthesia * expected blood loss \> 500 ml

Exclusion criteria

* Temporal bone window failure (substudy 1) * Cerebrovascular disease * Cardiac surgery * Neurosurgery

Design outcomes

Primary

MeasureTime frameDescription
Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulationup to 4 hours during surgerycalculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography
optimal MAP during NIRS-based measurement of cerebrovascular autoregulationup to 2 hours after surgeryMAP at lowest cerebral autoregulation index COx
delirium and postoperative NCD after surgery (composite)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

Secondary

MeasureTime frameDescription
length of hospital staydate of discharge from hospital (up to 30 days)duration of hospital stay (in days) between surgery and discharge
optimal MAP during TCD-based measurement of cerebrovascular autoregulationup to 4 hours during surgeryMAP at lowest cerebral autoregulation index (Mx)
mortality at 3 months after surgery3 months after surgerysurvival status three months after surgery
length of ICU staydate of discharge from ICU (up to 30 days)duration of intensive care unit stay (in days) between surgery and discharge
postoperative delirium between day 1 and 4 after surgerydays 1 to 4 after surgeryscreening for postoperative delirium
delayed neurocognitive recovery at day 7 after surgery or before hospital dischargeday 7 after surgery or at day of discharge from hospitalneuropsychological assessment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026