Cerebrovascular CirculationSONICANCT04978558
NIRS vs TCD for Cerebrovascular Autoregulation During Non-cardiac Surgery
An observational study of Cerebrovascular Circulation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebrovascular Circulation
- What is being tested?
- Continuous assessment of cerebrovascular autoregulation with NIRS and TCD
- How many people
- 509 participants
- Where
- 1 siteGermany
- Study dates
- 9 Aug 2021to 19 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for non-cardiac surgery with general anesthesia at a tertiary care hospital
Who may be able to join
- Age ≥ 18 years
- Elective surgery with a minimum duration of 120 minutes
- General anesthesia
- expected blood loss > 500 ml
Who cannot join
- Temporal bone window failure (substudy 1)
- Cerebrovascular disease
- Cardiac surgery
- Neurosurgery
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Medical Center Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography
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.
Read more
The study includes three substudies:
- 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.
- To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
- To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.
- Conditions
- Cerebrovascular Circulation
- Being tested
- Continuous assessment of cerebrovascular autoregulation with NIRS and TCD
- Keywords
- postoperative neurocognitive disorders, postoperative delirium, near-infrared spectroscopy, transcranial Doppler sonography, non-cardiac surgery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous assessment of cerebrovascular autoregulation with NIRS and TCDOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation
calculation of cerebral autoregulation indices based on near-infrared spectroscopy and transcranial Doppler sonography
Measured: up to 4 hours during surgery
optimal MAP during NIRS-based measurement of cerebrovascular autoregulation
MAP at lowest cerebral autoregulation index COx
Measured: up to 2 hours after surgery
delirium and postoperative NCD after surgery (composite)
screening for postoperative delirium; neuropsychological testing for the assessment of cognitive function
Measured: days 1 to 4 after surgery (delirium), day 7 after surgery or at day of discharge from hospital (NCD)
Secondary outcomes (6)
optimal MAP during TCD-based measurement of cerebrovascular autoregulation
MAP at lowest cerebral autoregulation index (Mx)
Measured: up to 4 hours during surgery
postoperative delirium between day 1 and 4 after surgery
screening for postoperative delirium
Measured: days 1 to 4 after surgery
delayed neurocognitive recovery at day 7 after surgery or before hospital discharge
neuropsychological assessment
Measured: day 7 after surgery or at day of discharge from hospital
length of hospital stay
duration of hospital stay (in days) between surgery and discharge
Measured: date of discharge from hospital (up to 30 days)
length of ICU stay
duration of intensive care unit stay (in days) between surgery and discharge
Measured: date of discharge from ICU (up to 30 days)
mortality at 3 months after surgery
survival status three months after surgery
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start9 Aug 2021
- Primary completion29 Sep 2023
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular CirculationStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Fischer, MD, PhD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978558
- Sponsor's protocol ID
- SONICA
- Acronym
- SONICA
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2021
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrovascular Autoregulation During Major Non-cardiac Surgery - a Comparison Between Near Infrared Spectroscopy and Transcranial Doppler Sonography
- ClinicalTrials.gov ID
- NCT04978558
- Acronym / sponsor ID
- SONICA / SONICA
- Conditions
- Cerebrovascular Circulation
- Keywords
- postoperative neurocognitive disorders, postoperative delirium, near-infrared spectroscopy, transcranial Doppler sonography, non-cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To compare MAP for optimal cerebrovascular autoregulation before induction of general anesthesia with MAP for optimal cerebrovascular autoregulation during or after general anesthesia.
- To analyze the association between the time-weighted average MAP below the MAP for optimal cerebrovascular autoregulation and postoperative NCD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-cardiac surgery with general anesthesia at a tertiary care hospital
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Elective surgery with a minimum duration of 120 minutes
- General anesthesia
- expected blood loss > 500 ml
Key exclusion criteria (4 listed)
- Temporal bone window failure (substudy 1)
- Cerebrovascular disease
- Cardiac surgery
- Neurosurgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous assessment of cerebrovascular autoregulation with NIRS and TCDContinuous monitoring of MAP, cerebral oxygenation, and cerebral blood flow velocity before, during, and after surgery to calculate two cerebrovascular autoregulation indices Cox and Mx. | Other | – |
Primary outcome
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
optimal MAP during NIRS-based measurement of cerebrovascular autoregulation
Time frame: up to 2 hours after surgery
MAP at lowest cerebral autoregulation index COx
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
6 secondary outcomes
optimal MAP during TCD-based measurement of cerebrovascular autoregulation
Time frame: up to 4 hours during surgery
postoperative delirium between day 1 and 4 after surgery
Time frame: days 1 to 4 after surgery
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
length of hospital stay
Time frame: date of discharge from hospital (up to 30 days)
length of ICU stay
Time frame: date of discharge from ICU (up to 30 days)
mortality at 3 months after surgery
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Fischer, MD, PhD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Circulation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Equivalence of NIRS-based and TCD-based intraoperative measurement of cerebrovascular autoregulation (time frame: up to 4 hours during surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.