A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomy.

Context A clear preference for intravenous or inhalationalanaesthesia has not been established for craniotomy in patientswithout signs of cerebral hypertension.Objectives The NeuroMorfeo trial was designed to testequivalence of inhalational and intravenous anaesthesiamaintenance techniques in the postoperative recovery ofpatients undergoing elective supratentorial surgery.Design This trial is a multicentre, randomised, open-label,equivalence design. A balanced stratified randomisationscheme was maintained using a centralised randomisationservice. Equivalence was tested using the two one-sided testsprocedure.Setting Fourteen Italian neuroanaesthesia centres participatedin the study from December 2007 to March 2009.Patients Adults, 18 to 75 years old, scheduled for electivesupratentorial intracranial surgery under general anaesthesiawereeligibleforenrolmentiftheyhadanormalpreoperativelevelof consciousness and no clinical signs of intracranialhypertension.Interventions Patients were randomised to one of threeanaesthesiamaintenanceprotocolstodetermineifsevoflurane–remifentanil or sevoflurane–fentanyl were equivalent topropofol–remifentanil.MainoutcomemeasuresTheprimaryoutcomewasthetimetoachieve an Aldrete postanaesthesia score of at least 9 aftertracheal extubation. Secondary endpoints includedhaemodynamic parameters, quality of the surgical field,perioperative neuroendocrine stress responses and routinepostoperative assessments.ResultsFourhundredandelevenpatients[51%men,meanage54.8 (SD 13.3) years] were enrolled. Primary outcome datawere available for 380. Median (interquartiles) times to reach anAldrete score of at least 9 were 3.48 (2.02 to 7.56), 3.25 (1.21to 6.45) and 3.32min (1.40 to 8.33) for sevoflurane–fentanyl,sevoflurane–remifentanil and propofol–remifentanilanaesthesia respectively, which confirmed equivalence usingthe two one-sided tests approach. Between-treatmentdifferences in haemodynamic variables were small and notclinically relevant. Urinary catecholamine and cortisol responseshad significantly lower activation with propofol–remifentanil.Postoperative pain and analgesic requirements weresignificantly higher in the remifentanil groups.Conclusion Equivalence was shown for inhalational andintravenous maintenance anaesthesia in times to reach anAldrete score of at least 9 after tracheal extubation.Haemodynamic variables, the quality of surgical field andpostoperative assessments were also similar. Perioperativeendocrine stress responses were significantly blunted withpropofol–remifentanil and higher analgesic requirements wererecorded in the remifentanil groups. Trial registration: Eudract2007–005279-32.Eur J Anaesthesiol 2012; 29:000–000