EUCTR2007-005279-32-ITActive, not recruitingNot Applicable
ANESTHESIOLOGICAL STRATEGIES IN ELECTIVE CRANIOTOMY: RANDOMIZED, EQUIVALENCE, OPEN TRIAL - NeuroMorfeo
A.O. San Gerardo di Monza0 sitesStarted: October 12, 2007Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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