Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation

NCT ID: NCT00830843

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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Recent study has shown that inhalatory sedation is a practicable, effective and not risky method in Intensive Care Unit. Sevoflurane effect on cerebral system have been described in previous studies: it causes an increasing of cerebral blood flow and a decrease of oxygen cerebral consumption. Clinical strategy for Subarachnoid Hemorrhage is orientated to increase cerebral blood flow to limit vasospasm phenomena after SAH. Scope of this study is to evaluate the Cerebral Blood Flow variation associated to Isoflurane sedation versus conventional sedation with propofol .

Detailed Description

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Conditions

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Stroke Subarachnoid Hemorrhage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Propofol

Propofol(3-4 mg/kg/ora)administrated for 2 hours.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol(3-4 mg/kg/ora)administrated for 2 hours.

Isoflurane

Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration

Group Type EXPERIMENTAL

Isoflurane

Intervention Type DRUG

Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration

Interventions

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Propofol

Propofol(3-4 mg/kg/ora)administrated for 2 hours.

Intervention Type DRUG

Isoflurane

Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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Inclusion Criteria

* diagnosis of aSAH
* indication to DVE positioning
* clinical indication to sedation and assisted ventilation
* indication to ICP and CBF monitoring
* age \> 18

Exclusion Criteria

* documented cranial hypertension (ICP\>18) not controller by liquor drainage
* age \< 18.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera San Gerardo di Monza

OTHER

Sponsor Role lead

Responsible Party

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Prof. Giuseppe Citerio

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Federico Villa, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera San Gerardo Monza

Locations

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Azienda Ospedaliera San Gerardo

Monza, Monza, Italy

Site Status

Countries

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Italy

References

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Newberg LA, Milde JH, Michenfelder JD. The cerebral metabolic effects of isoflurane at and above concentrations that suppress cortical electrical activity. Anesthesiology. 1983 Jul;59(1):23-8. doi: 10.1097/00000542-198307000-00005.

Reference Type BACKGROUND
PMID: 6859608 (View on PubMed)

Maekawa T, Tommasino C, Shapiro HM, Keifer-Goodman J, Kohlenberger RW. Local cerebral blood flow and glucose utilization during isoflurane anesthesia in the rat. Anesthesiology. 1986 Aug;65(2):144-51. doi: 10.1097/00000542-198608000-00003.

Reference Type BACKGROUND
PMID: 3740503 (View on PubMed)

Reinstrup P, Ryding E, Algotsson L, Messeter K, Asgeirsson B, Uski T. Distribution of cerebral blood flow during anesthesia with isoflurane or halothane in humans. Anesthesiology. 1995 Feb;82(2):359-66. doi: 10.1097/00000542-199502000-00006.

Reference Type BACKGROUND
PMID: 7856894 (View on PubMed)

Zhao P, Peng L, Li L, Xu X, Zuo Z. Isoflurane preconditioning improves long-term neurologic outcome after hypoxic-ischemic brain injury in neonatal rats. Anesthesiology. 2007 Dec;107(6):963-70. doi: 10.1097/01.anes.0000291447.21046.4d.

Reference Type BACKGROUND
PMID: 18043065 (View on PubMed)

Zhao P, Zuo Z. Isoflurane preconditioning induces neuroprotection that is inducible nitric oxide synthase-dependent in neonatal rats. Anesthesiology. 2004 Sep;101(3):695-703. doi: 10.1097/00000542-200409000-00018.

Reference Type BACKGROUND
PMID: 15329594 (View on PubMed)

McAuliffe JJ, Joseph B, Vorhees CV. Isoflurane-delayed preconditioning reduces immediate mortality and improves striatal function in adult mice after neonatal hypoxia-ischemia. Anesth Analg. 2007 May;104(5):1066-77, tables of contents. doi: 10.1213/01.ane.0000260321.62377.74.

Reference Type BACKGROUND
PMID: 17456654 (View on PubMed)

Zheng S, Zuo Z. Isoflurane preconditioning induces neuroprotection against ischemia via activation of P38 mitogen-activated protein kinases. Mol Pharmacol. 2004 May;65(5):1172-80. doi: 10.1124/mol.65.5.1172.

Reference Type BACKGROUND
PMID: 15102945 (View on PubMed)

Lee JJ, Li L, Jung HH, Zuo Z. Postconditioning with isoflurane reduced ischemia-induced brain injury in rats. Anesthesiology. 2008 Jun;108(6):1055-62. doi: 10.1097/ALN.0b013e3181730257.

Reference Type BACKGROUND
PMID: 18497606 (View on PubMed)

Kapinya KJ, Lowl D, Futterer C, Maurer M, Waschke KF, Isaev NK, Dirnagl U. Tolerance against ischemic neuronal injury can be induced by volatile anesthetics and is inducible NO synthase dependent. Stroke. 2002 Jul;33(7):1889-98. doi: 10.1161/01.str.0000020092.41820.58.

Reference Type BACKGROUND
PMID: 12105371 (View on PubMed)

L'her E, Dy L, Pili R, Prat G, Tonnelier JM, Lefevre M, Renault A, Boles JM. Feasibility and potential cost/benefit of routine isoflurane sedation using an anesthetic-conserving device: a prospective observational study. Respir Care. 2008 Oct;53(10):1295-303.

Reference Type BACKGROUND
PMID: 18811990 (View on PubMed)

Berton J, Sargentini C, Nguyen JL, Belii A, Beydon L. AnaConDa reflection filter: bench and patient evaluation of safety and volatile anesthetic conservation. Anesth Analg. 2007 Jan;104(1):130-4. doi: 10.1213/01.ane.0000248221.44383.43.

Reference Type BACKGROUND
PMID: 17179257 (View on PubMed)

Sackey PV, Martling CR, Nise G, Radell PJ. Ambient isoflurane pollution and isoflurane consumption during intensive care unit sedation with the Anesthetic Conserving Device. Crit Care Med. 2005 Mar;33(3):585-90. doi: 10.1097/01.ccm.0000156294.92415.e2.

Reference Type BACKGROUND
PMID: 15753751 (View on PubMed)

Sackey PV, Martling CR, Granath F, Radell PJ. Prolonged isoflurane sedation of intensive care unit patients with the Anesthetic Conserving Device. Crit Care Med. 2004 Nov;32(11):2241-6. doi: 10.1097/01.ccm.0000145951.76082.77.

Reference Type BACKGROUND
PMID: 15640636 (View on PubMed)

Villa F, Iacca C, Molinari AF, Giussani C, Aletti G, Pesenti A, Citerio G. Inhalation versus endovenous sedation in subarachnoid hemorrhage patients: effects on regional cerebral blood flow. Crit Care Med. 2012 Oct;40(10):2797-804. doi: 10.1097/CCM.0b013e31825b8bc6.

Reference Type DERIVED
PMID: 22824929 (View on PubMed)

Other Identifiers

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1-citerio

Identifier Type: -

Identifier Source: org_study_id

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