Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00741351
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2008-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anesthesiological Strategies in Elective Craniotomy
Sponsor:
Organization:
Raw JSON
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Why we still use intravenous drugs as the basic regimen for neurosurgical anaesthesia. Curr Opin Anaesthesiol. 2006 Oct;19(5):498-503. doi: 10.1097/01.aco.0000245274.69292.ad.'}, {'pmid': '8512094', 'type': 'BACKGROUND', 'citation': 'Todd MM, Warner DS, Sokoll MD, Maktabi MA, Hindman BJ, Scamman FL, Kirschner J. A prospective, comparative trial of three anesthetics for elective supratentorial craniotomy. Propofol/fentanyl, isoflurane/nitrous oxide, and fentanyl/nitrous oxide. Anesthesiology. 1993 Jun;78(6):1005-20. doi: 10.1097/00000542-199306000-00002.'}, {'pmid': '16960482', 'type': 'BACKGROUND', 'citation': 'Engelhard K, Werner C. Inhalational or intravenous anesthetics for craniotomies? Pro inhalational. Curr Opin Anaesthesiol. 2006 Oct;19(5):504-8. doi: 10.1097/01.aco.0000245275.76916.87.'}, {'pmid': '16037733', 'type': 'BACKGROUND', 'citation': '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 Anesthesiol. 2005 Jul;17(3):134-8. doi: 10.1097/01.ana.0000167447.33969.16.'}, {'pmid': '12145066', 'type': 'BACKGROUND', 'citation': 'Talke P, Caldwell JE, Brown R, Dodson B, Howley J, Richardson CA. A comparison of three anesthetic techniques in patients undergoing craniotomy for supratentorial intracranial surgery. Anesth Analg. 2002 Aug;95(2):430-5, table of contents. doi: 10.1097/00000539-200208000-00036.'}, {'pmid': '12947355', 'type': 'BACKGROUND', 'citation': '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 Sep;146(3):398-403. doi: 10.1016/S0002-8703(03)00324-7.'}, {'pmid': '7772368', 'type': 'BACKGROUND', 'citation': 'Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.'}, {'pmid': '10866905', 'type': 'BACKGROUND', 'citation': '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. Anesth Analg. 2000 Jul;91(1):163-9. doi: 10.1097/00000539-200007000-00030.'}, {'pmid': '16675939', 'type': 'BACKGROUND', 'citation': '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 May;72(5):309-19. English, Italian.'}, {'pmid': '3828169', 'type': 'BACKGROUND', 'citation': '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 Feb;59(2):184-8. doi: 10.1093/bja/59.2.184.'}, {'pmid': '16427527', 'type': 'BACKGROUND', 'citation': 'Nishiyama T, Yamashita K, Yokoyama T. Stress hormone changes in general anesthesia of long duration: isoflurane-nitrous oxide vs sevoflurane-nitrous oxide anesthesia. J Clin Anesth. 2005 Dec;17(8):586-91. doi: 10.1016/j.jclinane.2005.03.009.'}, {'pmid': '10927999', 'type': 'BACKGROUND', 'citation': 'Desborough JP. The stress response to trauma and surgery. Br J Anaesth. 2000 Jul;85(1):109-17. doi: 10.1093/bja/85.1.109. No abstract available.'}, {'pmid': '6696213', 'type': 'BACKGROUND', 'citation': '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 Jan;39(1):19-23. doi: 10.1111/j.1365-2044.1984.tb09447.x.'}, {'pmid': '8686529', 'type': 'BACKGROUND', 'citation': '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(1):77-80. doi: 10.1007/BF01411728.'}, {'pmid': '16301244', 'type': 'BACKGROUND', 'citation': '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 anesthesia. Anesth Analg. 2005 Dec;101(6):1700-1705. doi: 10.1213/01.ane.0000184041.32175.14.'}, {'pmid': '16027252', 'type': 'BACKGROUND', 'citation': '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 Jul 26;112(4):465-70. doi: 10.1161/CIRCULATIONAHA.104.518449. Epub 2005 Jul 18.'}, {'pmid': '12172288', 'type': 'BACKGROUND', 'citation': 'Olsen KS, Pedersen CB, Madsen JB, Ravn LI, Schifter S. Vasoactive modulators during and after craniotomy: relation to postoperative hypertension. J Neurosurg Anesthesiol. 2002 Jul;14(3):171-9. doi: 10.1097/00008506-200207000-00001.'}, {'pmid': '12093125', 'type': 'BACKGROUND', 'citation': 'Leslie K, Troedel S. Does anaesthesia care affect the outcome following craniotomy? J Clin Neurosci. 2002 May;9(3):231-6. doi: 10.1054/jocn.2001.0934. No abstract available.'}, {'pmid': '727414', 'type': 'BACKGROUND', 'citation': 'Hall GM, Young C, Holdcroft A, Alaghband-Zadeh J. Substrate mobilisation during surgery. A comparison between halothane and fentanyl anaesthesia. Anaesthesia. 1978 Nov-Dec;33(10):924-30.'}, {'pmid': '15920188', 'type': 'BACKGROUND', 'citation': 'Fung D, Cohen M, Stewart S, Davies A. Can the Iowa Satisfaction with Anesthesia Scale be used to measure patient satisfaction with cataract care under topical local anesthesia and monitored sedation at a community hospital? Anesth Analg. 2005 Jun;100(6):1637-1643. doi: 10.1213/01.ANE.0000154203.00434.23.'}, {'pmid': '10955671', 'type': 'BACKGROUND', 'citation': '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(7):769-76. doi: 10.1007/s007010070091.'}, {'pmid': '14520540', 'type': 'BACKGROUND', 'citation': 'Piper I, Citerio G, Chambers I, Contant C, Enblad P, Fiddes H, Howells T, Kiening K, Nilsson P, Yau YH; BrainIT Group. The BrainIT group: concept and core dataset definition. Acta Neurochir (Wien). 2003 Aug;145(8):615-28; discussion 628-9. doi: 10.1007/s00701-003-0066-6.'}, {'pmid': '16522836', 'type': 'BACKGROUND', 'citation': 'Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006 Mar 8;295(10):1152-60. doi: 10.1001/jama.295.10.1152.'}, {'pmid': '16522835', 'type': 'BACKGROUND', 'citation': 'Le Henanff A, Giraudeau B, Baron G, Ravaud P. Quality of reporting of noninferiority and equivalence randomized trials. JAMA. 2006 Mar 8;295(10):1147-51. doi: 10.1001/jama.295.10.1147.'}, {'pmid': '16818930', 'type': 'BACKGROUND', 'citation': 'Kaul S, Diamond GA. Good enough: a primer on the analysis and interpretation of noninferiority trials. Ann Intern Med. 2006 Jul 4;145(1):62-9. doi: 10.7326/0003-4819-145-1-200607040-00011.'}, {'pmid': '19348675', 'type': 'DERIVED', 'citation': 'Citerio G, Franzosi MG, Latini R, Masson S, Barlera S, Guzzetti S, Pesenti A. Anaesthesiological strategies in elective craniotomy: randomized, equivalence, open trial--the NeuroMorfeo trial. Trials. 2009 Apr 6;10:19. doi: 10.1186/1745-6215-10-19.'}]}, 'descriptionModule': {'briefSummary': 'This protocol, NeuroMorfeo, aims to assess equivalence between volatile and intravenous anesthetics for neurosurgical procedures.', 'detailedDescription': "NeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for a elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state evaluated with the ASA (I-III) and Glasgow Coma Scale (GCS) equal to 15, will be randomly assigned to one of three anesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanesthesia will be evaluated by comparing the intervals required to reach, after anesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned: 1) sevoflurane + fentanyl vs. propofol + remifentanil; 2) sevoflurane + remifentanil vs. propofol + remifentanil.\n\nSecondary end-points include: an assessment of neurovegetative stress based on (a) measurement urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anesthesia; intraoperative adverse events (i.e. hypotension, hypertension, requirement of osmotic agents or/and hyperventilation for controlling brain swelling); evaluation of surgical field; postoperative adverse events (as seizures, cough, shivering, agitation, postoperative hematoma and postoperative pain); patient's satisfaction and an analysis of costs.\n\n411 patients will be recruited in 14 different Italian centers during an 18-month period.\n\nThe recruitment started December 20th, 2007 and up to 11th March 2009."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patient scheduled for elective intracranial surgery under general anesthesia for a supratentorial mass lesion in the next 24 hours;\n* Physical state, evaluated with the ASA (American Society of Anesthesiologists ) classification I (normal healthy patient), II (patient with mild systemic disease), or III (patient with severe systemic disease);\n* Age 18-75 years;\n* Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;\n* No signs of intracranial hypertension.\n\nExclusion criteria:\n\n* Severe cardiovascular pathology, as uncontrolled arterial hypertension, documented reduced coronary reserve.\n* Renal or liver disease precluding the use of either anesthetic technique.\n* Pregnancy .\n* Known allergies to any anesthetic agent.\n* Reduced preoperative level of consciousness, i.e.\n* Glasgow Coma Scale (GCS) \\< 15.\n* Body weight greater than 120 kg.\n* History of drug abuse or psychiatric conditions.\n* Documented disturbance of the hypothalamic region.Refusal to sign consent form.\n* Participation in other clinical trials.\n* Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.'}, 'identificationModule': {'nctId': 'NCT00741351', 'acronym': 'Neuromorfeo', 'briefTitle': 'Anesthesiological Strategies in Elective Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera San Gerardo di Monza'}, 'officialTitle': 'Anesthesiological Strategies in Elective Craniotomy: Randomized, Equivalence, Open Trial', 'orgStudyIdInfo': {'id': 'EudraCT number 2007-005279-32'}, 'secondaryIdInfos': [{'id': 'AIFA FARM6FKJKK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IF', 'description': 'Sevoflurane (Inhalation)+Fentanyl', 'interventionNames': ['Drug: Sevoflurane + Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'IR', 'description': 'Sevoflurane (Inhalation)+Remifentanyl', 'interventionNames': ['Drug: Sevoflurane + Remifentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'ER', 'description': 'Propofol (Endovenous)+ Remifentanyl', 'interventionNames': ['Drug: Propofol + Remifentanyl']}], 'interventions': [{'name': 'Sevoflurane + Fentanyl', 'type': 'DRUG', 'description': 'Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and fentanyl (2-3 microg/kg/hr or 0.7 microg/kg boluses). Just before incision of the scalp, fentanyl (1-2microg/kg/hr) can be supplemented, if necessary', 'armGroupLabels': ['IF']}, {'name': 'Sevoflurane + Remifentanyl', 'type': 'DRUG', 'description': 'Sevoflurane is maintained in a MAC range (0.75% to 1.25%) and remifentanil (0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening). Just before incision of the scalp, remifentanil can be supplemented, if necessary', 'armGroupLabels': ['IR']}, {'name': 'Propofol + Remifentanyl', 'type': 'DRUG', 'description': 'Propofol is maintained with continuous infusion at 10 mg/kg/h for the first 10 minutes, then reduced to 8 mg/kg/h for the following 10 minutes and reduced to 6mg/kg/h thereafter and remifentanil 0.5-0.25 microg/kg/min reduced to 0.05-0.1 microg/kg/min after dural opening. Just before incision of the scalp, remifentanil could be supplemented, if necessary', 'armGroupLabels': ['ER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bari', 'country': 'Italy', 'facility': 'Policlinico Consorziale di Bari', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '40100', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Bellaria Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Fondazione San Raffaele Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20052', 'city': 'Monza', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Gerardo', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'Ospedale Maggiore della Carità di Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Ospedale di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '43100', 'city': 'Parma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Parma', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico "A. Gemelli" Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Policlinico "Umberto I" Roma', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '53100', 'city': 'Siena', 'country': 'Italy', 'facility': 'Azienda Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'zip': '10057', 'city': 'Turin', 'country': 'Italy', 'facility': 'Ospedale San Giovanni Bosco Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Turin', 'country': 'Italy', 'facility': 'Ospedale San giovanni Battista Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi Varese', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '37121', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'Giuseppe Citerio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera San Gerardo Monza'}, {'name': 'Antonio Pesenti, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Università delgi Studi Milano Bicocca'}, {'name': 'Maria Grazia Franzosi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Di Ricerche Farmacologiche Mario Negri'}, {'name': 'Roberto Latini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Di Ricerche Farmacologiche Mario Negri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera San Gerardo di Monza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Dott. Giuseppe Citerio', 'investigatorAffiliation': 'Azienda Ospedaliera San Gerardo di Monza'}}}}