Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial

Giuseppe Citerio, Maria Grazia Franzosi, Roberto Latini, Serge Masson, Simona Barlera, Stefano Guzzetti, Antonio Pesenti, Giuseppe Citerio, Maria Grazia Franzosi, Roberto Latini, Serge Masson, Simona Barlera, Stefano Guzzetti, Antonio Pesenti

Abstract

Background: Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaesthesiological strategy depends only on the anaesthetists' preferences or institutional policies. This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures.

Methods/design: NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III) and Glasgow Coma Scale (GCS) equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score > or = 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 of urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anaesthesia; intraoperative adverse events; evaluation of surgical field; postoperative adverse events; patient's satisfaction and analysis of costs. 411 patients will be recruited in 14 Italian centers during an 18-month period.

Discussion: We presented the development phase of this anaesthesiological on-going trial. The recruitment started December 4th, 2007 and up to 4th, December 2008, 314 patients have been enrolled.

Trial registration: ClinicalTrials.gov NCT00741351.

Figures

Figure 1
Figure 1
Scheme of blood and urine samples for stress biomarkers (cortisol and catecholamines). For each patient samples are collected before the induction, during surgical procedure and after awakening to evaluate within-patient changes.

References

    1. Hans P, Bonhomme V. Why we still use intravenous drugs as the basic regimen for neurosurgical anaesthesia. Curr Opin Anaesthesiol. 2006;19:498–503. doi: 10.1097/.
    1. Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anaesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anaesthesiology. 1993;78:1005–1020. doi: 10.1097/00000542-199306000-00002.
    1. Engelhard K, Werner C. Inhalational or intravenous anaesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006;19:504–508. doi: 10.1097/01.aco.0000245275.76916.87.
    1. Dinsmore J. Anaesthesia for elective neurosurgery. Br J Anaesth. 2007;99:68–74. doi: 10.1093/bja/aem132.
    1. Magni G, Baisi F, La Rosa I, Imperiale C, Fabbrini V, Pennacchiotti ML, Rosa G. No difference in emergence time and early cognitive function between sevoflurane-fentanyl and propofol-remifentanil in patients undergoing craniotomy for supratentorial intracranial surgery. J Neurosurg Anaesthesiol. 2005;17:134–138. doi: 10.1097/01.ana.0000167447.33969.16.
    1. Aldrete JA. The post-anaesthesia recovery score revisited. J Clin Anaesth. 1995;7:89–91. doi: 10.1016/0952-8180(94)00001-K.
    1. Balakrishnan G, Raudzens P, Samra SK, Song K, Boening JA, Bosek V, Jamerson BD, Warner DS. A comparison of remifentanil and fentanyl in patients undergoing surgery for intracranial mass lesions. Anaesth Analg. 2000;91:163–169. doi: 10.1097/00000539-200007000-00030.
    1. Talke P, Caldwell JE, Brown R, Dodson B, Howley J, Richardson CA. A comparison of three anaesthetic techniques in patients undergoing craniotomy for supratentorial intracranial surgery. Anaesth Analg. 2002;95:430–435. doi: 10.1097/00000539-200208000-00036.
    1. Boztug N, Bigat Z, Akyuz M, Demir S, Ertok E. Does using the bispectral index (BIS) during craniotomy affect the quality of recovery? J Neurosurg Anaesthesiol. 2006;18:1–4. doi: 10.1097/01.ana.0000188028.80960.dd.
    1. Del Gaudio A, Ciritella P, Perrotta F, Puopolo M, Lauta E, Mastronardi P, De Vivo P. Remifentanil vs fentanyl with a target controlled propofol infusion in patients undergoing craniotomy for supratentorial lesions. Minerva Anestesiol. 2006;72:309–319.
    1. Lauta E, Abbinante C, Del Gaudio A, Aloj F, Fanelli M, De Vivo P, Fiore T. Inhalation vs. intravenous anaesthesia for elective supratentorial craniotomy: a prospective, randomized trial (preliminary report) SNACC 2003 ABSTRACTS. 2003. p. A44.
    1. Gomberg-Maitland M, Frison L, Halperin JL. Active-control clinical trials to establish equivalence or noninferiority: methodological and statistical concepts linked to quality. Am Heart J. 2003;146:398–403. doi: 10.1016/S0002-8703(03)00324-7.
    1. Klingstedt C, Giesecke K, Hamberger B, Jarnberg PO. High- and low-dose fentanyl anaesthesia: circulatory and plasma catecholamine responses during cholecystectomy. Br J Anaesth. 1987;59:184–188. doi: 10.1093/bja/59.2.184.
    1. Parker SD, Breslow MJ, Frank SM, Rosenfeld BA, Norris EJ, Christopherson R, Rock P, Gottlieb SO, Raff H, Perler BA, et al. Catecholamine and cortisol responses to lower extremity revascularization: correlation with outcome variables. Perioperative Ischemia Randomized Anaesthesia Trial Study Group. Crit Care Med. 1995;23:1954–1961. doi: 10.1097/00003246-199512000-00003.
    1. Nishiyama T, Yamashita K, Yokoyama T. Stress hormone changes in general anaesthesia of long duration: isoflurane-nitrous oxide vs sevoflurane-nitrous oxide anaesthesia. J Clin Anaesth. 2005;17:586–591. doi: 10.1016/j.jclinane.2005.03.009.
    1. Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000;85:109–117. doi: 10.1093/bja/85.1.109.
    1. Bent JM, Paterson JL, Mashiter K, Hall GM. Effects of high-dose fentanyl anaesthesia on the established metabolic and endocrine response to surgery. Anaesthesia. 1984;39:19–23. doi: 10.1111/j.1365-2044.1984.tb09447.x.
    1. Heesen M, Deinsberger W, Dietrich GV, Detsch O, Boldt J, Hempelmann G. Increase of interleukin-6 plasma levels after elective craniotomy: influence of interleukin-10 and catecholamines. Acta Neurochir (Wien) 1996;138:77–80. doi: 10.1007/BF01411728.
    1. Ledowski T, Bein B, Hanss R, Paris A, Fudickar W, Scholz J, Tonner PH. Neuroendocrine stress response and heart rate variability: a comparison of total intravenous versus balanced anaesthesia. Anaesth Analg. 2005;101:1700–1705. doi: 10.1213/01.ane.0000184041.32175.14.
    1. Guzzetti S, Borroni E, Garbelli PE, Ceriani E, Della Bella P, Montano N, Cogliati C, Somers VK, Malliani A, Porta A. Symbolic dynamics of heart rate variability: a probe to investigate cardiac autonomic modulation. Circulation. 2005;112:465–470. doi: 10.1161/CIRCULATIONAHA.104.518449.
    1. Olsen KS, Pedersen CB, Madsen JB, Ravn LI, Schifter S. Vasoactive modulators during and after craniotomy: relation to postoperative hypertension. J Neurosurg Anaesthesiol. 2002;14:171–179. doi: 10.1097/00008506-200207000-00001.
    1. Leslie K, Troedel S. Does anaesthesia care affect the outcome following craniotomy? J Clin Neurosci. 2002;9:231–236. doi: 10.1054/jocn.2001.0934.
    1. Hall GM, Young C, Holdcroft A, Alaghband-Zadeh J. Substrate mobilisation during surgery. A comparison between halothane and fentanyl anaesthesia. Anaesthesia. 1978;33:924–930. doi: 10.1111/j.1365-2044.1978.tb08427.x.
    1. Donald Fung MC, Stewart Susan, Davies Andy. Can the Iowa Satisfaction with Anaesthesia Scale be used to measure patient satisfaction with cataract care under topical local anaesthesia and monitored sedation at a community hospital? Anaesth Analg. 2005;100:1637–1643. doi: 10.1213/01.ANE.0000154203.00434.23.
    1. Citerio G, Stocchetti N, Cormio M, Beretta L. Neuro-Link, a computer-assisted database for head injury in intensive care. Acta Neurochir (Wien) 2000;142:769–776. doi: 10.1007/s007010070091.
    1. Piper I, Citerio G, Chambers I, Contant C, Enblad P, Fiddes H, Howells T, Kiening K, Nilsson P, Yau YH. The BrainIT group: concept and core dataset definition. Acta Neurochir (Wien) 2003;145:615–628. doi: 10.1007/s00701-003-0066-6. discussion 628-619.
    1. Citerio G, Gaini SM, Tomei G, Stocchetti N. Management of 350 aneurysmal subarachnoid hemorrhages in 22 Italian neurosurgical centers. Intensive Care Med. 2007;33:1580–1586. doi: 10.1007/s00134-007-0700-5.
    1. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. Jama. 2006;295:1152–1160. doi: 10.1001/jama.295.10.1152.
    1. Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. Jama. 2006;295:1147–1151. doi: 10.1001/jama.295.10.1147.
    1. Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006;145:62–69.

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere