ANESTHESIOLOGICAL STRATEGIES IN ELECTIVE CRANIOTOMY: RANDOMIZED, EQUIVALENCE, OPEN TRIAL - NeuroMorfeo
- Conditions
- Study population. This is a multicenter randomized, open label, controlled trial, utilizing an equivalence design and evaluating three different anesthesiological strategies in patients undergoing supratentorial elective neurosurgery.MedDRA version: 9.1Level: LLTClassification code 10053302Term: Nervous system surgery
- Registration Number
- EUCTR2007-005279-32-IT
- Lead Sponsor
- A.O. San Gerardo di Monza
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion. Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I-III. Age 18-75 years. Glasgow Coma Scale (GCS) = 15. No signs of intracranial hypertension.
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
Severe cardiovascular pathology. Renal or liver disease precluding the use of either anesthetic technique. Pregnancy . Known allergies to any anesthetic agent. Glasgow Coma Scale (GCS) < 15. Body weight >120 kg. History of drug abuse or psychiatric conditions. Documented disturbance of the hypothalamic region. Refusal to sign consent form. Participation in other clinical trials. Delayed awakening, because postoperative sedation and mechanical ventilation are planned.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method