A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomy
- PMID: 22569025
- DOI: 10.1097/EJA.0b013e32835422db
A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomy
Abstract
Context: A clear preference for intravenous or inhalational anaesthesia has not been established for craniotomy in patients without signs of cerebral hypertension.
Objectives: The NeuroMorfeo trial was designed to test equivalence of inhalational and intravenous anaesthesia maintenance techniques in the postoperative recovery of patients undergoing elective supratentorial surgery.
Design: This trial is a multicentre, randomised, open-label, equivalence design. A balanced stratified randomisation scheme was maintained using a centralised randomisation service. Equivalence was tested using the two one-sided tests procedure.
Setting: Fourteen Italian neuroanaesthesia centres participated in the study from December 2007 to March 2009.
Patients: Adults, 18 to 75 years old, scheduled for elective supratentorial intracranial surgery under general anaesthesia were eligible for enrolment if they had a normal preoperative level of consciousness and no clinical signs of intracranial hypertension.
Interventions: Patients were randomised to one of three anaesthesia maintenance protocols to determine if sevoflurane-remifentanil or sevoflurane-fentanyl were equivalent to propofol-remifentanil.
Main outcome measures: The primary outcome was the time to achieve an Aldrete postanaesthesia score of at least 9 after tracheal extubation. Secondary endpoints included haemodynamic parameters, quality of the surgical field, perioperative neuroendocrine stress responses and routine postoperative assessments.
Results: Four hundred and eleven patients [51% men, mean age 54.8 (SD 13.3) years] were enrolled. Primary outcome data were available for 380. Median (interquartiles) times to reach an Aldrete score of at least 9 were 3.48 (2.02 to 7.56), 3.25 (1.21 to 6.45) and 3.32 min (1.40 to 8.33) for sevoflurane-fentanyl, sevoflurane-remifentanil and propofol-remifentanil anaesthesia respectively, which confirmed equivalence using the two one-sided tests approach. Between-treatment differences in haemodynamic variables were small and not clinically relevant. Urinary catecholamine and cortisol responses had significantly lower activation with propofol-remifentanil. Postoperative pain and analgesic requirements were significantly higher in the remifentanil groups.
Conclusion: Equivalence was shown for inhalational and intravenous maintenance anaesthesia in times to reach an Aldrete score of at least 9 after tracheal extubation. Haemodynamic variables, the quality of surgical field and postoperative assessments were also similar. Perioperative endocrine stress responses were significantly blunted with propofol-remifentanil and higher analgesic requirements were recorded in the remifentanil groups.
Trial registration: Eudract 2007-005279-32.
Comment in
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Research on neuroanaesthesia and real outcomes.Eur J Anaesthesiol. 2012 Aug;29(8):360-1. doi: 10.1097/EJA.0b013e32835522cb. Eur J Anaesthesiol. 2012. PMID: 22786552 No abstract available.
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Comparing oranges with apples?Eur J Anaesthesiol. 2013 Apr;30(4):191. doi: 10.1097/EJA.0b013e32835c1be4. Eur J Anaesthesiol. 2013. PMID: 23241917 No abstract available.
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Reply to: Comparing oranges with apples?Eur J Anaesthesiol. 2013 Apr;30(4):192-3. doi: 10.1097/EJA.0b013e32835ca09f. Eur J Anaesthesiol. 2013. PMID: 23429280 No abstract available.
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Anaesthetic considerations in measuring Aldrete score and long-term outcomes in craniotomy patients.Eur J Anaesthesiol. 2013 Sep;30(9):576-7. doi: 10.1097/EJA.0b013e328360b0b4. Eur J Anaesthesiol. 2013. PMID: 23702599 No abstract available.
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Reply to: anaesthetic considerations in measuring Aldrete score and long-term outcomes in craniotomy patients.Eur J Anaesthesiol. 2013 Sep;30(9):577-8. doi: 10.1097/EJA.0b013e328360b0c9. Eur J Anaesthesiol. 2013. PMID: 23907529 No abstract available.
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Iowa Satisfaction with Anesthesia Scale for general anaesthesia.Eur J Anaesthesiol. 2014 Jan;31(1):62. doi: 10.1097/EJA.0b013e328365407b. Eur J Anaesthesiol. 2014. PMID: 24225727 No abstract available.
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