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

NCT ID: NCT04164329

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-10-31

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.

Conditions

General Anesthetics Toxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Exposed group

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

General anesthetic

Intervention Type: DRUG

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

Not exposed group

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

No interventions assigned to this group

Interventions

General anesthetic

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardiocentro Ticino

OTHER

Sponsor Role: lead

Responsible Party

Tiziano Cassina

Professor med. Tiziano Cassina

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tiziano TC Cassina, Professor

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino

Stefania SB Buson, Dr.ssa

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino

Locations

Cardiocentro Ticino

Lugano, Canton Ticino, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Stefania SB Buson, Dr.

Role: CONTACT

Stefania.Buson@cardiocentro.org

+41 91 805 31 85

Tiziano TC Cassina, Professor

Role: CONTACT

Tiziano.Cassina@cardiocentro.org

+41 91 805 31 83

Facility Contacts

Tiziano TC Cassina, MD

Role: primary

tiziano.cassina@cardiocentro.org

+41 (0)91 8053183

Other Identifiers

2019-01739

Identifier Type: -

Identifier Source: org_study_id