Different Anesthesiological Strategies Evaluation in Deep Brain Stimulation Neurosurgeries - DBS
- Conditions
- Parkinson Desease
- Registration Number
- EUCTR2009-015867-15-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Patients selected for elective neurosurgical interventions related to the implantation of intracranial electrodes deep. - Good physical condition assessed in accordance with the general scale ASA (American Society of Anesthesiology, http://www.asahq.org/clinical/physicalstatus.htm) with classification I to III. - Age between 18-75 years. - Normal preoperative supervision and safety for both the strategies Anesthetic (not contraindications for both).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Presence of severe cardiovascular disease (uncontrolled hypertension, lack of documented coronary reserve). - The presence of liver or kidney disease that preclude the use of certain techniques anesthetic considered. - Pregnancy. - Known allergy to any form of anesthetic. - Weight> 120 Kg - History of drug abuse or psychiatric disorders. - Participation in other clinical studies over the past two months. - Inability or refusal of informed consent in expression.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the study is to assess whether general anesthesia is superior, related to the occurrence of adverse events, to the conventional strategy (local anesthesia + general anesthesia) for neurosurgical planting of deep intracranial electrodes (Deep Brain Stimulation).;Secondary Objective: - Activation of the autonomic nervous system through: - Activation of the sympathetic system (assessed by biomarkers), - ECG analysis. - Assessment of post-operative adverse events - Evaluation of the surgical field. - Surgical outcome, evaluated by the application dell`Unified Parkinson`s Disease Rating Scale. - Satisfaction of the patient;Primary end point(s): Assessment of intraoperative adverse events in both anesthetical strategies.
- Secondary Outcome Measures
Name Time Method