Document Detail


A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomy.
MedLine Citation:
PMID:  22569025     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Giuseppe Citerio; Antonio Pesenti; Roberto Latini; Serge Masson; Simona Barlera; Flavio Gaspari; Maria G Franzosi;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  European journal of anaesthesiology     Volume:  29     ISSN:  1365-2346     ISO Abbreviation:  Eur J Anaesthesiol     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-07-12     Completed Date:  2012-11-21     Revised Date:  2014-01-13    
Medline Journal Info:
Nlm Unique ID:  8411711     Medline TA:  Eur J Anaesthesiol     Country:  England    
Other Details:
Languages:  eng     Pagination:  371-9     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Airway Extubation
Analgesics, Opioid / administration & dosage
Analysis of Variance
Anesthesia, Inhalation* / adverse effects
Anesthesia, Intravenous* / adverse effects
Anesthetics, Inhalation / administration & dosage*,  adverse effects
Anesthetics, Intravenous / administration & dosage*,  adverse effects
Biological Markers / blood
Chi-Square Distribution
Craniotomy* / adverse effects
Female
Fentanyl / administration & dosage
Hemodynamics / drug effects
Humans
Italy
Linear Models
Male
Methyl Ethers / administration & dosage*,  adverse effects
Middle Aged
Pain, Postoperative / etiology,  prevention & control
Piperidines / administration & dosage
Propofol / administration & dosage*,  adverse effects
Recovery of Function
Shivering / drug effects
Surgical Procedures, Elective
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Analgesics, Opioid; 0/Anesthetics, Inhalation; 0/Anesthetics, Intravenous; 0/Biological Markers; 0/Methyl Ethers; 0/Piperidines; 28523-86-6/sevoflurane; P10582JYYK/remifentanil; UF599785JZ/Fentanyl; YI7VU623SF/Propofol
Investigator
Investigator/Affiliation:
Giuseppe Citerio / ; Antonio Pesenti / ; Roberto Latini / ; Maria G Franzosi / ; F Sala / ; A Vargiolu / ; E Finocchio / ; S Villa / ; L Beretta / ; M Gemma / ; E Nicelli / ; G Licini / ; A Caricato / ; M Antonelli / ; M Munari / ; S M Volpin / ; M Grandis / ; M Sergi / ; M Zanello / ; S Gualdani / ; C Testoni / ; F Della Corte / ; P Konrad / ; T Fontana / ; C Montagnini / ; E Adale / ; R Potenza / ; S Livigni / ; M Berardino / ; S Cavallo / ; M M Garbarino / ; O Morrone / ; R Tinturini / ; E Zei / ; G Stofella / ; F Casagrande / ; F Procaccio / ; M Mergoni / ; P Ceccarelli / ; T Serioli / ; F Bilotta / ; G Rosa / ; C Abbinante / ; E Lauta / ; Serge Masson / ; Roberto Latini / ; L Perico / ; R Bernasconi / ; Flavio Gaspari / ; N Stucchi / ; A N Cannata / ; S Guzzetti / ; T Bassani / ; E Nicolis / ; Simona Barlera / ; G Cappellini / ; L Ferrario / ; G Tognoni / ; S M Imbaro / ; R Malacrida / ; S M Gaini / ; D Menon / ; B Gregson /
Comments/Corrections
Comment In:
Eur J Anaesthesiol. 2014 Jan;31(1):62   [PMID:  24225727 ]
Eur J Anaesthesiol. 2013 Apr;30(4):192-3   [PMID:  23429280 ]
Eur J Anaesthesiol. 2013 Apr;30(4):191   [PMID:  23241917 ]
Eur J Anaesthesiol. 2013 Sep;30(9):576-7   [PMID:  23702599 ]
Eur J Anaesthesiol. 2013 Sep;30(9):577-8   [PMID:  23907529 ]
Eur J Anaesthesiol. 2012 Aug;29(8):360-1   [PMID:  22786552 ]

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