Anesthesiological Strategies in Elective Craniotomy
Condition: Anesthesia; Craniotomy; Neurosurgery
Study type: Interventional
Phase: Phase 3

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

Detailed description: 
      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.
    

Intervention name(s): Sevoflurane + Fentanyl; Sevoflurane + Remifentanyl; Propofol + Remifentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary; Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary; Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary
Intervention MeSH terms: Fentanyl; Remifentanil; Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia; Craniotomy; Neurosurgery