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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT00830843
First received: January 27, 2009
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)

Resource links provided by NLM:

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 ]

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
Other Name: Isoflurane

  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 cranial hypertension (ICP>18) not controller by liquor drainage
  • age < 18.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dott. Giuseppe Citerio, MD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT00830843     History of Changes
Other Study ID Numbers: 1-citerio
Study First Received: January 27, 2009
Last Updated: November 30, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera San Gerardo di Monza:
SAH
sedation
anesthesia

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

ClinicalTrials.gov processed this record on June 17, 2013