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

Primary Purpose

Stroke, Subarachnoid Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Propofol
Isoflurane
Sponsored by
Azienda Ospedaliera San Gerardo di Monza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring SAH, sedation, anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Azienda Ospedaliera San Gerardo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Propofol

Isoflurane

Arm Description

Propofol(3-4 mg/kg/ora)administrated for 2 hours.

Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration

Outcomes

Primary Outcome Measures

Cerebral Blood Flow

Secondary Outcome Measures

Full Information

First Posted
January 27, 2009
Last Updated
August 19, 2016
Sponsor
Azienda Ospedaliera San Gerardo di Monza
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1. Study Identification

Unique Protocol Identification Number
NCT00830843
Brief Title
Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation
Acronym
GAS-SAH
Official Title
Inhalatorial Sedation in Patient With SAH Versus Conventional Intravenous Sedation (GAS-SAH)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera San Gerardo di Monza

4. Oversight

Data Monitoring Committee
No

5. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Subarachnoid Hemorrhage
Keywords
SAH, sedation, anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Propofol(3-4 mg/kg/ora)administrated for 2 hours.
Arm Title
Isoflurane
Arm Type
Experimental
Arm Description
Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
Propofol(3-4 mg/kg/ora)administrated for 2 hours.
Intervention Type
Drug
Intervention Name(s)
Isoflurane
Intervention Description
Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
Primary Outcome Measure Information:
Title
Cerebral Blood Flow
Time Frame
after 2 hours of drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico Villa, MD
Organizational Affiliation
Azienda Ospedaliera San Gerardo Monza
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera San Gerardo
City
Monza
Country
Italy

12. IPD Sharing Statement

Citations:
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6859608
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PubMed Identifier
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Citation
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Inhalatorial Sedation in Patient With Subarachnoid Hemorrhage (SAH) Versus Conventional Intravenous Sedation

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