Anesthetic Neurotoxicity: the Association Between General Anesthesia and the Level of Plasma Neurofilament Light
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in plasma Neurofilament Light levels
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patients with history of neurodegenerative diseases and neurocognitive disorders: the presence of these disorders could influence the level of the neuro-markers.
研究组 & 干预措施
Exposed group
The exposed group will be composed by the patients that undergo CRT/ICD implantation (general anesthesia).
干预措施: General anesthetic (Drug)
结局指标
主要结局
Changes in plasma Neurofilament Light levels
时间窗: 24 hours
Comparison of changes in plasma Neurofilament Light levels pre and postoperative in patients exposed and not exposed to general anesthesia.
次要结局
- Changes in plasma Neurofilament Light levels and acute postoperative neurocognitive disorders(48 hours)
研究者
Tiziano Cassina
Professor med. Tiziano Cassina
Cardiocentro Ticino