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

General Anesthetics Toxicity Clinical Trial

— ANESTOX-2019  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164329
• Other study ID #: 2019-01739
• Status: Recruiting
• Start date: November 11, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2019
• Source: Cardiocentro Ticino
• Contact: Stefania SB Buson, Dr.
• Phone: +41 91 805 31 85
• Email: Stefania.Buson[@]cardiocentro.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Secondary endpoints: Association between the changes in plasma Neurofilament Light levels and the development of post-operative neurocognitive disorders as acute delirium.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthetics Toxicity
• Neurotoxicity Syndromes

Intervention

Drug:
• General anesthetic
General anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium)

Locations

Country	Name	City	State
Switzerland	Cardiocentro Ticino	Lugano	Canton Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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.	48 hours