General Anesthetics ToxicityANESTOX-2019NCT04164329
Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
An observational study of General Anesthetics Toxicity, run by Cardiocentro Ticino at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- General Anesthetics Toxicity
- What is being tested?
- General anesthetic
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2019to 31 Oct 2020
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Patients with history of neurodegenerative diseases and neurocognitive disorders: the presence of these disorders could influence the level of the neuro-markers.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Cardiocentro Ticino
Lugano, Canton Ticino, 6900
Tiziano TC Cassina, MD, +41 (0)91 8053183, tiziano.cassina@cardiocentro.org
Stefania SB Buson, DR
About this study
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.
Read the 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.
- Conditions
- General Anesthetics Toxicity
- Being tested
- General anesthetic
- Keywords
- Neurotoxicity, anesthesia, Neurofilament Light
- Medical subject headings
- Neurotoxicity Syndromes, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anestheticDrug
General anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium)
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | The exposed group will be composed by the patients that undergo CRT/ICD implantation (general anesthesia). Receives: Drug: General anesthetic | |
| Not exposed group | The non-exposed group, or control group, will be composed by the patients undergo PM implantation (without anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma Neurofilament Light levels
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to general anesthesia.
Measured: 24 hours
Secondary outcomes (1)
Changes in plasma Neurofilament Light levels and acute postoperative neurocognitive disorders
Association between the changes in plasma Neurofilament Light levels and the development of post-operative neurocognitive disorders as acute delirium.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start11 Nov 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthetics ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Cardiocentro Ticino
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiziano Cassina, Cardiocentro Ticino
- Investigators
- Tiziano TC Cassina, Professor, Principal investigator, Cardiocentro TicinoStefania SB Buson, Dr.ssa, Principal investigator, Cardiocentro Ticino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164329
- Sponsor's protocol ID
- 2019-01739
- Other IDs
- 2019
- Acronym
- ANESTOX-2019
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
- ClinicalTrials.gov ID
- NCT04164329
- Acronym / sponsor ID
- ANESTOX-2019 / 2019-01739
- Conditions
- General Anesthetics Toxicity
- Keywords
- Neurotoxicity, anesthesia, Neurofilament Light
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cardiocentro TicinoUniversity, hospital or other
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: General anestheticThe exposed group will be composed by the patients that undergo CRT/ICD implantation (general anesthesia). |
| Not exposed group | – | –The non-exposed group, or control group, will be composed by the patients undergo PM implantation (without anesthesia) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with history of neurodegenerative diseases and neurocognitive disorders: the presence of these disorders could influence the level of the neuro-markers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anestheticGeneral anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium) | Drug | Exposed group |
Primary outcome
Changes in plasma Neurofilament Light levels
Time frame: 24 hours
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to general anesthesia.
1 secondary outcome
Changes in plasma Neurofilament Light levels and acute postoperative neurocognitive disorders
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiziano TC Cassina, Professor principal investigator
Cardiocentro Ticino
Stefania SB Buson, Dr.ssa principal investigator
Cardiocentro Ticino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthetics Toxicity, run by Cardiocentro Ticino at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania SB Buson, Dr. (+41 91 805 31 85, Stefania.Buson@cardiocentro.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma Neurofilament Light levels (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.