Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation - Full Text View

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

This study is currently recruiting participants.

Verified by Azienda Ospedaliera San Gerardo di Monza, August 2009

First Received: January 27, 2009 Last Updated: August 3, 2009 History of Changes

Sponsored by:	Azienda Ospedaliera San Gerardo di Monza
Information provided by:	Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:	NCT00830843

Purpose

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 .

Condition	Intervention	Phase
Stroke Subarachnoid Hemorrhage	Drug: Propofol Drug: Isoflurane	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Gas

Drug Information available for: Isoflurane Propofol

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:

Cerebral Blood Flow [ Time Frame: after 2 hours of drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	13
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Propofol(3-4 mg/kg/ora)administrated for 2 hours.	Drug: Propofol Propofol(3-4 mg/kg/ora)administrated for 2 hours.
2: Experimental Isoflurano inalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concetration	Drug: Isoflurane Isoflurano inalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concetration

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 cranical hypertension (ICP>18) not controller by liquor drainage
age < 18.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00830843

Contacts

Contact: Giuseppe Citerio, MD	0039392334316	g.citerio@hsgerardo.org
Contact: Federico Villa, MD	0039392334337

Locations

Italy
Azienda Ospedaliera San Gerardo	Recruiting
Monza, Italy
Contact: Giuseppe Citerio, MD 0039392334613 g.citerio@hsgerardo.org
Contact: Eliana Finocchio, PhD 0039392334335 fineliana@hotmail.it
Principal Investigator: Giuseppe Citerio, MD
Principal Investigator: Federico Villa, MD
Sub-Investigator: Eliana Finocchio, PhD

Sponsors and Collaborators

Azienda Ospedaliera San Gerardo di Monza

Investigators

Principal Investigator:

Federico Villa, MD

Azienda Ospedaliera San Gerardo Monza

More Information

Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Kapinya KJ, Löwl D, Fütterer 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.

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.

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.

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.

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.

Responsible Party:	Azienda Ospedaliera San Gerardo Monza ( Giuseppe Citerio )
Study ID Numbers:	1-citerio
Study First Received:	January 27, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00830843 History of Changes
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera San Gerardo di Monza:

SAH
sedation
anesthesia

Study placed in the following topic categories:

Anesthetics, Intravenous
Chlorhexidine
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Depressants
Central Nervous System Diseases
Anesthetics
Intracranial Hemorrhages
Hemorrhage

Brain Diseases
Cerebrovascular Disorders
Anesthetics, Inhalation
Anesthetics, General
Chlorhexidine gluconate
Hypnotics and Sedatives
Isoflurane
Subarachnoid Hemorrhage
Flatulence
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Nervous System Diseases
Vascular Diseases
Central Nervous System Depressants
Anesthetics
Central Nervous System Diseases
Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Cerebrovascular Disorders

Pharmacologic Actions
Anesthetics, Inhalation
Pathologic Processes
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Subarachnoid Hemorrhage
Isoflurane
Cardiovascular Diseases
Propofol
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 03, 2009