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: 9.1 Level: LLT Classification code 10053302 Term: Nervous system surgery
Conditions
Interventions
Product Name: Sevoflurane
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: Sevoflurane
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 250-
Pro
Sponsors
A.O. San Gerardo di Monza
Eligibility
Sex/Gender
All
Inclusion criteria
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
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study aim is to evaluate whether the conventional strategy (inhalatory anesthesia) is equivalent to intravenous anesthesia for supratentorial elective neurosurgery.;Secondary Objective: The study will also evaluate the equivalence of the different anesthesiological strategies in terms of: Neurovegetative system activation, comparing differences in cortisol and cathecolamines in the three groups. Intraoperative adverse events, i.e. hypotension, hypertension, requirement for osmotic or/and hyperventilation. Surgical evaluation of the surgical field Postoperative adverse events, as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain. Costs.;Primary end point(s): The primary endpoint is the interval required in the three anesthesia groups (inhalatory vs. intravenous group) to obtain a modified Aldrete score >= 9. An anesthetist, blinded to the patient assignment, will measure the time to reach the target score. The interval will be calculated starting from the completion of the surgical dressing and anesthesia termination. The score will be obtained adding up the points achieved in each of the five domains. | — |
Countries
Italy
Outcome results
None listed