| A multicentre, randomised, open-label, controlled trial evaluating equivalence of inhalational and intravenous anaesthesia during elective craniotomy. | |
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MedLine Citation:
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PMID: 22569025 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Giuseppe Citerio; Antonio Pesenti; Roberto Latini; Serge Masson; Simona Barlera; Flavio Gaspari; Maria G Franzosi; |
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Publication Detail:
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Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: European journal of anaesthesiology Volume: 29 ISSN: 1365-2346 ISO Abbreviation: Eur J Anaesthesiol Publication Date: 2012 Aug |
Date Detail:
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Created Date: 2012-07-12 Completed Date: 2012-11-21 Revised Date: 2013-04-16 |
Medline Journal Info:
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Nlm Unique ID: 8411711 Medline TA: Eur J Anaesthesiol Country: England |
Other Details:
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Languages: eng Pagination: 371-9 Citation Subset: IM |
Affiliation:
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Neuroanesthesia and Neurointensive Care Unit, Anestesia e Rianimazione, San Gerardo Hospital, via Pergolesi 33, Monza 20900, Milano, Italy. g.citerio@hsgerardo.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Analgesics, Opioid; 0/Anesthetics, Inhalation; 0/Anesthetics, Intravenous; 0/Biological Markers; 0/Methyl Ethers; 0/Piperidines; 2078-54-8/Propofol; 28523-86-6/sevoflurane; 437-38-7/Fentanyl; P10582JYYK/remifentanil |
| Investigator | |
Investigator/Affiliation:
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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:
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Eur J Anaesthesiol. 2012 Aug;29(8):360-1
[PMID:
22786552
]
Eur J Anaesthesiol. 2013 Apr;30(4):192-3 [PMID: 23429280 ] Eur J Anaesthesiol. 2013 Apr;30(4):191 [PMID: 23241917 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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