Anesthesiological Strategies in Elective Craniotomy

Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial

This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.

NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.

Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.

411 patients will be recruited in 14 different Italian centers during an 18-month period.

The recruitment started December 20th, 2007 and up to 11th March 2009.

Inclusion criteria:

• Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;
• Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);
• Age 18-75 years;
• Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
• No signs of intracranial hypertension.

Exclusion criteria:

• Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.
• Renal or liver disease precluding the use of either anesthetic technique.
• Pregnancy .
• Known allergies to any anesthetic agent.
• Reduced preoperative level of consciousness, i.e.
• Glasgow Coma Scale (GCS) < 15.
• Body weight greater than 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, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.