NCT00830843

Brief Summary

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 stroke

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

August 22, 2016

Status Verified

November 1, 2011

Enrollment Period

2.5 years

First QC Date

January 27, 2009

Last Update Submit

August 19, 2016

Conditions

StrokeSubarachnoid Hemorrhage

Keywords

SAHsedationanesthesia

Outcome Measures

Primary Outcomes (1)

  • Cerebral Blood Flow

    after 2 hours of drug administration

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Isoflurane

EXPERIMENTAL

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

Drug: Isoflurane

Interventions

PropofolDRUG

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

Also known as: Diprivan
Propofol
IsofluraneDRUG

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

Isoflurane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • documented cranial hypertension (ICP\>18) not controller by liquor drainage
  • age \< 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera San Gerardo

Monza, Monza, Italy

Location

Related Publications (14)

  • 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.

    PMID: 6859608BACKGROUND

  • 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.

    PMID: 3740503BACKGROUND

  • 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.

    PMID: 7856894BACKGROUND

  • 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.

    PMID: 18043065BACKGROUND

  • 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.

    PMID: 15329594BACKGROUND

  • 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.

    PMID: 17456654BACKGROUND

  • 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.

    PMID: 15102945BACKGROUND

  • 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.

    PMID: 18497606BACKGROUND

  • 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.

    PMID: 12105371BACKGROUND

  • 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.

    PMID: 18811990BACKGROUND

  • 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.

    PMID: 17179257BACKGROUND

  • 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.

    PMID: 15753751BACKGROUND

  • 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.

    PMID: 15640636BACKGROUND

  • 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.

    PMID: 22824929DERIVED

MeSH Terms

Conditions

StrokeSubarachnoid Hemorrhage

Interventions

PropofolIsoflurane

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthers

Study Officials

  • Federico Villa, MD

    Azienda Ospedaliera San Gerardo Monza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 22, 2016

Record last verified: 2011-11

Locations

IT(1)