Orthopedic Surgery Clinical Trial
Official title:
Brain Power Spectral Density Under Propofol and Its Association With Cerebral Fragility, an Objective Means to Estimate the Probability of Presenting Burst Suppression
In the operating room, the state of anesthesia is monitored during general anesthesia-induced hypnosis through EEG-based neuro-monitoring. Recent studies suggest that variables extracted from per-operative EEG change as brain ages. Furthermore, aging is itself an independant factor associated to an increased sensitivity to General Anesthesia (GA). Among fragility sign, per-operative Burst Suppression (BS) has been associated to a poor postoperative cognitive trajectory. The main goal of this observational clinical study is to extend the traditional use of per-operative EEG to the detection and prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).
Main objective : Extend the traditional use of per-operative EEG to the detection and
prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).
Indices derived from the EEG signal, Spectral Edge Frequency 95 (SEF95), Patient State Index
(PSI) and Bi-spectral Index (BIS) are now widely used in the operating room to monitor the
Depth of Anesthesia (DoA). Recent studies suggest that variables extracted from per-operative
EEG change as brain ages. A detailed reading of the quantitative EEG (qEEG) under GA has been
recently described depending both on the specific drug used and patients' age. For GA induced
with Propofol (2,6 di-isopropylphenol), a GABAergic receptor agonist used in Total Intra
Venous Anesthesia (TIVA), the EEG signal under frontal derivations exhibits a specific
signature characterized by a powerful alpha band. However, the elderly attenuates these EEG
characteristics, which might be the results of a change in thalamic-cortical function and
decreased neuronal excitability.
The goal of this observational clinical study is to assess the fragility of a patient under
GA and based on the EEG SEF13 characteristics, weighted by the amount of Propofol
administered.
Measures are based on EEG signal and subfrequency power spectral densities including alpha
band as well as the amount of Propofol, each measured for EEG periods where SEF 95 = 8-13Hz.
Experimental design: This is a single-center, interventional, category I prospective study
(minimal risks and constraints)
Population concerned : Patients eligible for interventional neuroradiology or orthopedic
surgery performed under GA are selected to participate in this prospective, observational,
single-center, routine care study. Patients will be included if they received, for a
non-urgent scheduled procedure, a Total IntraVenous Administration (TIVA) anesthesia by
Propofol according to the Schnider model combined with a morphine derivative. Minor patients,
pregnant women and patients who refused to provide informed consent are excluded from the
study. Patients with a BMI > 36 kg/m2 for whom the Schnider model is not validated are also
excluded. Patient demographics will be collected during the anesthesia consultation. Total
IntraVenous Anesthesia (TIVA) and Target Controlled Infusion (TCI) are used for morphine
derivative and Propofol, EEG parameters will be collected from frontal electrodes montage
(Fp1, Fp2, F7, F8).
Research Proceedings : Measures are based on EEG signal through routine EEG-based
neuro-monitoring and subfrequency power spectral densities including alpha band as well as
the amount of Propofol, each measured for EEG periods where SEF95 = 8-13Hz. Standard
monitoring (Pulse Oxygen Saturation: SpO2, Heart Rate: HR, Systolic, Diastolic and Mean
Arterial Blood Pressure: SBP, DBP, MAP, Temperature, End tidal CO2: (EtCO2) and
electro-encephalogram monitoring by the Masimo Sedline monitor (SEF 95, PSI and BS) will be
recorded.
General anesthesia is then induced in a standardized manner with a morphine followed by
intra-venous administration of Propofol. All the measures are obtained non-invasively.
Individual benefit: There is no benefit for the patient
Collective benefit: Aging is associated to change in cerebral activity and it's crucial to
distinguishes fragile patients from normal ones. The tailoring of doses according to the
degree of "cerebral fragility" could predict poor postoperative cognitive or behavioral
evolution.
Risks and minimal constraints added by the research: No added risk. The procedure is
performed according to the usual protocol including routine EEG-based neuro-monitoring All
the measures are obtained non-invasively.
For all patients whatever the comorbidities, anesthesia induction will be performed using a
target-controlled infusion (Orchestra® Base Primea - Fresenius Kabi France). According to our
standard of care, intra-operative episodes of hypotension (mean arterial pressure (MAP) < 65
mmHg or < 80% baseline) are treated by Norepinephrine bolus of 10 μg. For all patients, data
from EEG-neuromonitoring and hemodynamic data are collected at the end of the procedure.
Number of selected subjects Selection of patients up to 60 analysable patients Number of
Centre : 1 Research Agenda inclusion period: 12 months duration of participation (treatment +
follow-up): duration of the interventional neuroradiology or orthopedic procedure: 1 day
total duration: 12 months Number of planned inclusions by centre and month : 5 Number of
subjects required : 60
Statistics The significance level used in this study chose as 0.05. The values is expressed
in percentage for qualitative variables and median (InterQuartile Range: [IQR]) for
quantitative variables. All parameters will be recorded and the brain total power spectral
density (PT), alpha band power spectral density (Pα) and the Propofol TCI (µg/ml) will be
calculated on the entire population. The median value of Pα,PT,PropofolTCI combination will
be compared using non-parametric Kruskal Wallis and Man Whitney tests for quantitative data,
while qualitative variable will be analyzed based on the Fisher's test. Research on the
correlation between age and brain total power spectral is carried out by Pearson's test.
Then analysis will be also performed according to the occurrence of BS during induction of
anesthesia. ROC curves will be constructed from univariate logistic régressions. For each
univariate regression investigators provided Odd Ratios (OR) given with a 95% Confidence
Interval (CI) and Areas Under the Curve (AUC). Multivariate analysis is finally performed
with a logistic regression model where explanatory variables are chosen according to the
results of the univariate analysis (p-value≤0.1).
The sample size calculation is based on the following assumptions : Assuming an incidence of
40% BS, with a power at 80% and an alpha risk at 5%, it is necessary to include 60 patients
to highlight an area under the ROC curve of 80% with a confidence interval width of 0.1.
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