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

NCT04164329 | Unknown

• 1 other identifier: 2019-01739
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthetics Toxicity

Keywords

Neurotoxicity; anesthesia; Neurofilament Light

Outcome Measures

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.

  24 hours

Secondary Outcomes (1)

• Changes in plasma Neurofilament Light levels and acute postoperative neurocognitive disorders

  48 hours

Study Arms (2)

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

General anesthetic DRUG

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

Exposed group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cardiocentro Ticino: lead

Study Sites (1)

Cardiocentro Ticino

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Neurotoxicity Syndromes; Charcot-Marie-Tooth disease, Type 1F

Interventions

Anesthetics, General

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Tiziano TC Cassina, Professor

  Cardiocentro Ticino

  PRINCIPAL INVESTIGATOR

• Stefania SB Buson, Dr.ssa

  Cardiocentro Ticino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania SB Buson, Dr.

CONTACT

+41 91 805 31 85; Stefania.Buson@cardiocentro.org

Tiziano TC Cassina, Professor

CONTACT

+41 91 805 31 83; Tiziano.Cassina@cardiocentro.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor med. Tiziano Cassina

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 15, 2019
• Study Start: November 11, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)