Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
Sponsors
Source
Cardiocentro Ticino
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
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.
Detailed Description
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.
Overall Status
Recruiting
Start Date
2019-11-11
Completion Date
2020-10-31
Primary Completion Date
2020-10-31
Study Type
Observational [Patient Registry]
Primary Outcome
Measure |
Time Frame |
|
Changes in plasma Neurofilament Light levels |
24 hours |
Secondary Outcome
Measure |
Time Frame |
|
Changes in plasma Neurofilament Light levels and acute postoperative neurocognitive disorders |
48 hours |
Number Of Groups
2
Enrollment
120
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
General anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium)
Arm Group Label
Exposed group
Eligibility
Study Pop
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.
Sampling Method
Non-Probability Sample
Criteria
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Tiziano TC Cassina, Professor |
Principal Investigator |
Cardiocentro Ticino |
|
Stefania SB Buson, Dr.ssa |
Principal Investigator |
Cardiocentro Ticino |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Cardiocentro Ticino Lugano Canton Ticino 6900 Switzerland |
Recruiting |
Last Name: Stefania SB Buson, DR Role: Sub-Investigator Last Name: Michele MV Villa, RN Role: Sub-Investigator |
Location Countries
Country
Switzerland
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Cardiocentro Ticino
Investigator Full Name
Tiziano Cassina
Investigator Title
Professor med. Tiziano Cassina
Keywords
Has Expanded Access
No
Condition Browse
Intervention Browse
Mesh Term
Anesthetics
Anesthetics, General
Arm Group
Arm Group Label
Exposed group
Description
The exposed group will be composed by the patients that undergo CRT/ICD implantation (general anesthesia).
Arm Group Label
Not exposed group
Description
The non-exposed group, or control group, will be composed by the patients undergo PM implantation (without anesthesia)
Firstreceived Results Date
N/A
Overall Contact Backup
Biospec Retention
Samples Without DNA
Biospec Descr
blood samples
Acronym
ANESTOX-2019
Target Duration
2 Days
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
November 13, 2019
Study First Submitted Qc
November 14, 2019
Study First Posted
November 15, 2019
Last Update Submitted
November 15, 2019
Last Update Submitted Qc
November 15, 2019
Last Update Posted
November 18, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.