StrokePhase 4GAS-SAHNCT00830843
Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation
A Phase 4 study testing Propofol and Isoflurane in people with Stroke and Subarachnoid Hemorrhage, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Subarachnoid Hemorrhage
- What is being tested?
- Propofol and Isoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of aSAH
- indication to DVE positioning
- clinical indication to sedation and assisted ventilation
- indication to ICP and CBF monitoring
- age > 18
Who cannot join
- documented cranial hypertension (ICP>18) not controller by liquor drainage
- age < 18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)
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 .
- Conditions
- Stroke, Subarachnoid Hemorrhage
- Being tested
- Propofol, Isoflurane
- Keywords
- SAH, sedation, anesthesia
- Medical subject headings
- Stroke, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
Propofol(3-4 mg/kg/ora)administrated for 2 hours.
IsofluraneDrug
Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Propofol(3-4 mg/kg/ora)administrated for 2 hours. Receives: Drug: Propofol |
| Isoflurane | Experimental | Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Measured: after 2 hours of drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Federico Villa, MD, Principal investigator, Azienda Ospedaliera San Gerardo Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830843
- Sponsor's protocol ID
- 1-citerio
- Acronym
- GAS-SAH
- Status last verified
- Nov 2011
- First submitted
- 27 Jan 2009
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1097/00000542-198307000-00005.
PubMed 6859608Maekawa 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.
PubMed 3740503Reinstrup 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.
PubMed 7856894Zhao 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.
PubMed 18043065Zhao 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.
PubMed 15329594McAuliffe 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.
PubMed 17456654Zheng 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.
PubMed 15102945Lee 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.
PubMed 18497606Kapinya 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.
PubMed 12105371L'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.
PubMed 18811990Berton 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.
PubMed 17179257Sackey 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.
PubMed 15753751Sackey 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.
PubMed 15640636Villa 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.
PubMed 22824929
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)
- ClinicalTrials.gov ID
- NCT00830843
- Acronym / sponsor ID
- GAS-SAH / 1-citerio
- Conditions
- Stroke, Subarachnoid Hemorrhage
- Keywords
- SAH, sedation, anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolPropofol(3-4 mg/kg/ora)administrated for 2 hours. |
| Isoflurane | Experimental | Drug: IsofluraneIsoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of aSAH
- indication to DVE positioning
- clinical indication to sedation and assisted ventilation
- indication to ICP and CBF monitoring
- age > 18
Key exclusion criteria (2 listed)
- documented cranial hypertension (ICP>18) not controller by liquor drainage
- age < 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolAlso: DiprivanPropofol(3-4 mg/kg/ora)administrated for 2 hours. | Drug | Propofol |
| IsofluraneIsoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration | Drug | Isoflurane |
Primary outcome
Cerebral Blood Flow
Time frame: after 2 hours of drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 6859608Newberg 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.
- Background: PubMed 3740503Maekawa 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.
- Background: PubMed 7856894Reinstrup 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.
- Background: PubMed 18043065Zhao 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.
- Background: PubMed 15329594Zhao 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.
- Background: PubMed 17456654McAuliffe 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.
- Background: PubMed 15102945Zheng 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.
- Background: PubMed 18497606Lee 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.
- Background: PubMed 12105371Kapinya 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.
- Background: PubMed 18811990L'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.
- Background: PubMed 17179257Berton 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.
- Background: PubMed 15753751Sackey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federico Villa, MD principal investigator
Azienda Ospedaliera San Gerardo Monza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Isoflurane in people with Stroke and Subarachnoid Hemorrhage, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (time frame: after 2 hours of drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00830843, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.