Skip to content

Quantification of Dynamic and Static Cerebral Autoregulation (CA) Under Anaesthesia

Simultaneous Quantification of Dynamic and Static Cerebral Autoregulation (CA) at Different Steady-state Mean Blood Pressures Under Anaesthesia.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03816072
Acronym
SAMBA
Enrollment
66
Registered
2019-01-25
Start date
2019-01-07
Completion date
2019-09-23
Last updated
2021-05-27

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

Conditions

Cerebrovascular Circulation

Brief summary

Cerebral autoregulation (CA) is the mechanism by which the brain vasculature maintains constancy of cerebral blood flow (CBF). Reliable direct measurements of CBF at different blood pressure levels are difficult because they are invasive and time-consuming. This type of measurement to quantify CA is generally referred to as static cerebral autoregulation (sCA). Alternatively, it is possible to measure CA indirectly from blood pressure oscillations. Dynamic cerebral autoregulation (dCA) measures how quickly the cerebral vessels react to a change in blood pressure to normalize CBF. Since the introduction of transcranial Doppler ultrasound (TCD), it has become possible to estimate CBF velocity relatively easy, which in turn correlates well with CBF changes. This method is widely used to quantify dCA. However, it is not clear how sCA correlates with dCA over a range of physiologic mean blood pressure (MBP). It is important to compare different methods of assessing CA, because impaired CA may result in increased risk of perioperative complications such as stroke. In this study, the investigators were interested in establishing the relationship between sCA and dCA during surgery under general anesthesia. The investigators aim to compare these methods during propofol and sevoflurane anesthesia.

Interventions

Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.

OTHERMechanical ventilation

Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (\ 0.1 Hz).

DRUGPropofol

Propofol

DRUGSevoflurane

Sevoflurane

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Patients receive either propofol or sevoflurane to maintain anaesthesia. Both treatment groups receive the same phenylephrine and mechanical ventilation regimens.

Eligibility

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

Inclusion criteria

* ASA-I or ASA-II, willing and able to give written informed consent, scheduled for elective, non-cardiothoracic surgery under general anaesthesia and age 18 years and above.

Exclusion criteria

* Patient related * Unable/ unwilling to participate * ASA-III or higher * Age \< 18 years * History of: uncontrolled hypertension, diabetes, Parkinson's disease, uncontrolled cardiac arrhythmia, Pure autonomic failure (formerly called idiopathic orthostatic hypotension), Multiple system atrophy with autonomic failure (formerly called Shy-Drager syndrome), Addison's disease and hypopituitarism, pheochromocytoma, peripheral autonomic neuropathy (e.g., amyloid neuropathy, idiopathic autonomic neuropathy), known cardiomyopathy, extreme left ventricle hypertrophy or ejection fraction \< 30%, proven or suspected allergy for any of the medication used during induction of anaesthesia, malignant hyperthermia. * Unability to record transcranial Doppler ultrasound due to anatomical variance (\ 5% of population) * Contra-indications for intravenous or inhalational anaesthesia. * Contra-indications for phenylephrine: severe hypertension, peripheral vascular illness, severe hyperthyroidism * Simultaneous use of MAO-inhibitors, dopaminergic or vasoconstrictor ergot alkaloids (bromocriptine, cabergoline, pergolide, ergotamine, methylergometrine, methysergide), linezolid, tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, digoxin, quinidine, oxytocin. * Surgery related * Day case surgery * Laparoscopy with CO2 insufflation * Extreme positioning during surgery (head-down/up tilt, lateral decubitus position, prone) * Surgery \< 60 minutes.

Design outcomes

Primary

MeasureTime frame
Changes in dCA after several MBP-increasing steps.Intraoperatively
Differences in dCA between sevoflurane and propofol at different steady-state MBP's.Intraoperatively

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026