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

A

Azienda Ospedaliera San Gerardo di Monza

Status and phase

Completed
Phase 4

Conditions

Subarachnoid Hemorrhage
Stroke

Treatments

Drug: Isoflurane
Drug: Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT00830843
1-citerio

Details and patient eligibility

About

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 .

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Propofol
Active Comparator group
Description:
Propofol(3-4 mg/kg/ora)administrated for 2 hours.
Treatment:
Drug: Propofol
Isoflurane
Experimental group
Description:
Isoflurane inhalatorial administration for 2 hours at 0.8-1.0% Minimum Alveolar Concentration
Treatment:
Drug: Isoflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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