Study Results
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Basic Information
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COMPLETED
PHASE3
411 participants
INTERVENTIONAL
2007-12-31
2009-12-31
Brief Summary
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Detailed Description
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Secondary 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.
411 patients will be recruited in 14 different Italian centers during an 18-month period.
The recruitment started December 20th, 2007 and up to 11th March 2009.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IF
Sevoflurane (Inhalation)+Fentanyl
Sevoflurane + Fentanyl
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
IR
Sevoflurane (Inhalation)+Remifentanyl
Sevoflurane + Remifentanyl
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
ER
Propofol (Endovenous)+ Remifentanyl
Propofol + Remifentanyl
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
Interventions
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Sevoflurane + Fentanyl
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
Sevoflurane + Remifentanyl
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
Propofol + Remifentanyl
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
Eligibility Criteria
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Inclusion Criteria
* 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);
* Age 18-75 years;
* Normal preoperative level of consciousness, i.e. Glasgow Coma Scale (GCS) = 15;
* No signs of intracranial hypertension.
Exclusion Criteria
* Renal or liver disease precluding the use of either anesthetic technique.
* Pregnancy .
* Known allergies to any anesthetic agent.
* Reduced preoperative level of consciousness, i.e.
* Glasgow Coma Scale (GCS) \< 15.
* Body weight greater than 120 kg.
* History of drug abuse or psychiatric conditions.
* Documented disturbance of the hypothalamic region.Refusal to sign consent form.
* Participation in other clinical trials.
* Delayed awakening, because, due to the location or size of the lesion, postoperative sedation and mechanical ventilation are planned.
18 Years
75 Years
ALL
No
Sponsors
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Azienda Ospedaliera San Gerardo di Monza
OTHER
Responsible Party
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Dott. Giuseppe Citerio
MD
Principal Investigators
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Giuseppe Citerio, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera San Gerardo Monza
Antonio Pesenti, MD
Role: STUDY_CHAIR
Università delgi Studi Milano Bicocca
Maria Grazia Franzosi, PhD
Role: STUDY_CHAIR
Istituto Di Ricerche Farmacologiche Mario Negri
Roberto Latini, MD
Role: STUDY_CHAIR
Istituto Di Ricerche Farmacologiche Mario Negri
Locations
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Policlinico Consorziale di Bari
Bari, , Italy
Ospedale Bellaria Bologna
Bologna, , Italy
IRCCS Fondazione San Raffaele Milano
Milan, , Italy
Istituto di Ricerche Farmacologiche Mario Negri - Dipartimento di Ricerca Cardiovascolare-
Milan, , Italy
Azienda Ospedaliera San Gerardo
Monza, , Italy
Ospedale Maggiore della Carità di Novara
Novara, , Italy
Ospedale di Padova
Padua, , Italy
Azienda Ospedaliera di Parma
Parma, , Italy
Policlinico "A. Gemelli" Roma
Rome, , Italy
Policlinico "Umberto I" Roma
Rome, , Italy
Azienda Universitaria Senese
Siena, , Italy
Ospedale San Giovanni Bosco Torino
Turin, , Italy
Ospedale San giovanni Battista Torino
Turin, , Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, , Italy
Azienda Ospedaliera Universitaria di Verona
Verona, , Italy
Countries
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References
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Hans P, Bonhomme V. 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.
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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.
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.
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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.
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.
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.
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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.
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.
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.
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.
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.
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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.
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.
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Other Identifiers
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AIFA FARM6FKJKK
Identifier Type: -
Identifier Source: secondary_id
EudraCT number 2007-005279-32
Identifier Type: -
Identifier Source: org_study_id
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