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Status unknownNCT04164329ANESTOX-2019Updated Nov 18, 2019

Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light

An observational study in General Anesthetics Toxicity, sponsored by Cardiocentro Ticino. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Cardiocentro Ticino · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • General Anesthetics Toxicity

Keywords

  • Neurotoxicity
  • anesthesia
  • Neurofilament Light
03

In context

Neurotoxicity Syndromes

137 studies on the registry are indexed under Neurotoxicity Syndromes; 16 are open to participants now.

This study's planned enrollment of 120 is above the median of 86 across 38 observational studies indexed under Neurotoxicity Syndromes.

Browse Neurotoxicity Syndromes studies →

Lead sponsor

Cardiocentro Ticino is the lead sponsor of 13 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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

Exclusion Criteria:

  • Patients with history of neurodegenerative diseases and neurocognitive disorders: the presence of these disorders could influence the level of the neuro-markers.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (estimated)
Target follow-up
2 Days
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Exposed group

    The exposed group will be composed by the patients that undergo CRT/ICD implantation (general anesthesia).

    Drug: General anesthetic

  • Not exposed group

    The non-exposed group, or control group, will be composed by the patients undergo PM implantation (without anesthesia)

Interventions

  • DrugGeneral anesthetic

    General anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • Cardiocentro Ticino
    Lugano, Canton Ticino 6900, Switzerland
    • Tiziano TC Cassina, MD · Contact · tiziano.cassina@cardiocentro.org · +41 (0)91 8053183
    • Stefania SB Buson, DR · Sub investigator
    • Michele MV Villa, RN · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04164329
Lead sponsor
Cardiocentro Ticino
Responsible party
Tiziano Cassina (Professor med. Tiziano Cassina, Cardiocentro Ticino) — Principal investigator
First posted
Nov 15, 2019
Start date
Nov 11, 2019
Primary completion
Oct 31, 2020 (estimated)
Completion
Oct 31, 2020 (estimated)
Last update
Nov 18, 2019

Study contacts

Stefania SB Buson, Dr.
Contact
Stefania.Buson@cardiocentro.org
+41 91 805 31 85
Tiziano TC Cassina, Professor
Contact
Tiziano.Cassina@cardiocentro.org
+41 91 805 31 83
Tiziano TC Cassina, Professor
principal investigator · Cardiocentro Ticino
Stefania SB Buson, Dr.ssa
principal investigator · Cardiocentro Ticino

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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