General Anesthetics Toxicity Clinical Trial
Official title:
Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
A prospective controlled single centre study designed to determine the association between
the exposure to anesthetic agents and the pre and postoperative changes in plasma
Neurofilament Light levels, biomarkers of neurological injury, in patients with similar
surgical intervention but different anesthetic techniques.
Secondary endpoints: Association between the changes in plasma Neurofilament Light levels and
the development of post-operative neurocognitive disorders as acute delirium.
Our intent is to evaluate the impact of the general anesthesia on the Central Nervous System,
trying to minimize the surgical bias as much as possible. For this purpose, it is necessary
to consider two groups of patients who undergo to similar surgical intervention, but with
exposed to different anesthetic techniques. In particular, one group with local anesthesia
and one group with general anesthesia.
The population sample will be composed of all patients who satisfy the inclusion and
exclusion criteria and scheduled for the implantation of pacemaker (PM) - a procedure that
require a local anesthesia - and the implantation of a cardioverter defibrillator (ICD), a
cardiac resynchronization therapy pacemaker (CRT-P) and a cardiac resynchronization therapy
defibrillator (CRT-D) at the Cardiocentro Ticino Lugano, procedures usually realize under
general anesthesia.
The population sample will be divided in two groups: the non-exposed group, or control group,
will be composed by the patients undergo PM implantation (without anesthesia) and the exposed
group will be composed by the patients that undergo CRT/ICD implantation (general
anesthesia).
Inclusion criteria:
- Same type of surgery: ICD,CRT-P, CRT-D and PM implantation;
- Age > 18 years old
- Patients who have expressed their consent to the participation of the study
Exclusion criteria:
- Patients with history of neurodegenerative diseases and neurocognitive disorders: the
presence of these disorders could influence the level of the neuro-markers.
No change will be applied to normal clinical practice: we'll collect two blood samples, taken
from routine samples already performed in our clinical practice, for the dosage of
Neurofilament Light plasma levels before (t0) and after the procedure (t+24h).
Our intent is to compare the NF-L plasma levels delta (pre or t0 - postoperative or t24)
between the exposed group (general anesthesia) and the not exposed group (local anesthesia).
Blood samples will be collected and stored in EDTA at the times specified above and
anonymized. The samples, post anonymization, will be send to the University Hospital of Basel
(Basel, Switzerland) where the plasma concentration of neurodegeneration markers will be
blindly measured using the SiMoA neurology 4-plex assay.
The neurological status of the patients will be monitored daily during the first 2 days of
the post-operative course in intensive care or in the ward. The screening of the phenomenon
will be carried out by the nursing staff through the CAM-ICU and CAM (screening), in
accordance with the internal protocols. The screening will be performed and documented at
least three times a day or when the need is detected by the nursing staff. Any diagnosis of
delirium will be certified by the neurologist.
Exams or procedures that differ from normal clinical practice will not be performed, except
for the dosage of Neurofilament Light.
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