cerebrovascular microcirculation
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Craniotomy under general anesthesia - adults between 18 and 70 years of age - patient diagnosed with cerebral pathology that requires a craniotomy. Craniotomy awake - adults between 18 and 70 years - patient diagnosed with a lesion in an eloquent area of the brain, requiring an awake craniotomy.
Exclusion criteria
Exclusion criteria: child (<18y) or elderly (>70y), pregnancy, diabetes mellitus, familiar (combined) hyperlipidemia, smokers or patients with a history of smoking, history of stroke or other cardiovascular diseases, use of cardiovascular medication, silent signs of cerebral small vessel disease on brain MRI or previous cranial surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is perfused boundary region ((PBR), a continuous variable in expressed micrometers. PBR is presented as mean (±standard deviation) if normally distributed, and as median (range) if non-normally distributed. Differences between the groups will be calculated using t-test or Mann-Whitney U-test. Differences intra-individually before and after induction of general anesthesia will be calculated using t-test or Mann-Whitney U-test. Differences intra-individually between sublingual and cortical measurements will be calculated using t-test or Mann-Whitney U-test. Spearman rank correlation coefficient and uni- and multivariate regression analysis will be used to assess correlations between clinical (8.3.3. other study parameters) and PBR values. Missing data will be replaced by a mean or median value. p-value <0.05 is considered statistically significant. Given the pilot design and the explorative character of the study, the described statistics are primarily descriptive statistics, including testing the null-hypothesis and all microvascular properties. | — |
Secondary
| Measure | Time frame |
|---|---|
| Microvascular properties are expressed in different dimensions: - Perfused diameter (µm) - RBC velocity (µm/s) - perfused vessel density (mm/mm²) - Capillary blood volume (µm³) - Capillary recruitment capacity (%) Sublingual microvascular parameters will be compared between groups (anesthesia inhalation; anesthesia intravenous; awake) using the two-tailed student*s t-test or Mann-Whitney U-test or chi-square test. Cortical microvascular parameters will be compared between groups (anesthesia inhalation; anesthesia intravenous; awake) using t-test or Mann-Whitney U-test or chi-square test. Sublingual microvascular parameters intra-individually before and after induction of general anesthesia will be calculated using t-test or Mann-Whitney U-test or chi-square test. Cortical microvascular parameters intra-individually before and after induction of general anesthesia will be calculated using t-test or Mann-Whitney U-test or chi-square test. Sublingual and cortical microvascular parameters intra-individually will be calculated using t-test or Mann-Whitney U-test or chi-square test. P-value <0.05 is considered statistically significant. To correct for multiple testing in comparisons of microcirculation variables per-diameter class we use the false discovery rate (FDR) approach of Benjamini, Krieger and Yekutieli, setting a q value < 0.05 as significant. When results are not normally distributed, Mann-Whitney-U test will be performed. | — |
Countries
Netherlands
Outcome results
None listed