GAS-SAH: Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation
Sponsor
Azienda Ospedaliera San Gerardo di Monza (Other)
Overall Status
Completed
CT.gov ID
NCT00830843
Collaborator
(none)
13
1
2
29.9
0.4
Study Details
Study Description
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
13 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)
Study Start Date
:
Jan 1, 2009
Actual Primary Completion Date
:
Jul 1, 2011
Actual Study Completion Date
:
Jul 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Propofol Propofol(3-4 mg/kg/ora)administrated for 2 hours. |
Drug: Propofol
Propofol(3-4 mg/kg/ora)administrated for 2 hours.
Other Names:
|
| Experimental: Isoflurane Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration |
Drug: Isoflurane
Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
|
Outcome Measures
Primary Outcome Measures
- Cerebral Blood Flow [after 2 hours of drug administration]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera San Gerardo | Monza | Italy |
Sponsors and Collaborators
- Azienda Ospedaliera San Gerardo di Monza
Investigators
- Principal Investigator: Federico Villa, MD, Azienda Ospedaliera San Gerardo Monza
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Responsible Party:
Prof. Giuseppe Citerio,
MD,
Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT00830843
Other Study ID Numbers:
- 1-citerio
First Posted:
Jan 28, 2009
Last Update Posted:
Aug 22, 2016
Last Verified:
Nov 1, 2011
Keywords provided by Prof. Giuseppe Citerio,
MD,
Azienda Ospedaliera San Gerardo di Monza
Additional relevant MeSH terms: