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NCT Number: NCT04978558

NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous assessment of cerebrovascular autoregulation with NIRS and TCD

Other

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.

Primary outcomes

  1. Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation

    Time frame: up to 4 hours during surgery

    calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography

  2. optimal MAP during NIRS-based measurement of cerebrovascular autoregulation

    Time frame: up to 2 hours after surgery

    MAP at lowest cerebral autoregulation index COx

  3. delirium and postoperative NCD after surgery (composite)

    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

Secondary outcomes

  1. optimal MAP during TCD-based measurement of cerebrovascular autoregulation

    Time frame: up to 4 hours during surgery

    MAP at lowest cerebral autoregulation index (Mx)

  2. postoperative delirium between day 1 and 4 after surgery

    Time frame: days 1 to 4 after surgery

    screening for postoperative delirium

  3. delayed neurocognitive recovery at day 7 after surgery or before hospital discharge

    Time frame: day 7 after surgery or at day of discharge from hospital

    neuropsychological assessment

  4. length of hospital stay

    Time frame: date of discharge from hospital (up to 30 days)

    duration of hospital stay (in days) between surgery and discharge

  5. length of ICU stay

    Time frame: date of discharge from ICU (up to 30 days)

    duration of intensive care unit stay (in days) between surgery and discharge

  6. mortality at 3 months after surgery

    Time frame: 3 months after surgery

    survival status three months after surgery

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: SONICA

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 27, 2021
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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