Parkinson Desease
Conditions
Interventions
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Propofol
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical Form: So
Sponsors
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed