To assess the effects of anesthetics on local (cerebral) microvascular parameters in craniotomy patients. Secondary objective: To assess the effects of anesthetics on systemic (sublingual) microvascular parameters in craniotomy patients.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Cerebral microcirculation plays a significant role in various cerebral
diseases. Sidestream darkfield (SDF) videomicroscopy allows assessment of the
microcirculation in vivo. The SDF camera is either used sublingually, providing
assessment of the systemic microcirculation in many different disorders, or
directly on the brain in patients undergoing a craniotomy for various different
indications. This last technique allows us to study microvascular properties of
the brains of our craniotomy patients. Craniotomies are usually carried out
under general anesthesia, but are performed in awake patients as well.
Anesthetics are known to affect hemodynamic and microvascular properties. To
further investigate the role of microcirculation alterations in the
pathophysiology of neurological disorders, we first need to establish what part
of the effects can be attributed to anesthesia. We hypothesize that the
cerebrovascular microcirculation is affected by different types of anesthesia,
wherein general anesthesia has a greater detrimental effect compared to awake
surgery.
Study objective
To assess the effects of anesthetics on local (cerebral) microvascular
parameters in craniotomy patients.
Secondary objective: To assess the effects of anesthetics on systemic
(sublingual) microvascular parameters in craniotomy patients.
Study design
Observational cohort study with pilot design.
Study burden and risks
Given the burden of disease for oncology patients and patients with
neurological conditions, that is the consequence of our lack of
pathophysiological knowledge, and given the fact that our proposed study, which
is non-invasive and extremely low risk/low burden for the patient, will give us
unique information on the pathophysiology of microvascular disease, we think it
is justified to conduct the study. The sublingual measurements take place
during preparation of surgery, or during surgery itself and will not delay the
procedure, while the cortical measurement may only delay the procedure by 15
minutes (on a total surgery time of 3-4 hours), a time-investment we deem
justified when taking into account the huge amount of information we are
provided with. There are no registered complications in our previous glycocalyx
study.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85460.068.23 |