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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00830843
First Posted: January 28, 2009
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
  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 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:
  • Cerebral Blood Flow [ Time Frame: after 2 hours of drug administration ]

Enrollment: 13
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Diprivan
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 cranial hypertension (ICP>18) not controller by liquor drainage
  • age < 18.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00830843


Locations
Italy
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
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Giuseppe Citerio, MD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT00830843     History of Changes
Other Study ID Numbers: 1-citerio
First Submitted: January 27, 2009
First Posted: January 28, 2009
Last Update Posted: August 22, 2016
Last Verified: November 2011

Keywords provided by Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza:
SAH
sedation
anesthesia

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Propofol
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation