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

August 19, 2016 updated by: Prof. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy
        • Azienda Ospedaliera San Gerardo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cerebral Blood Flow
Time Frame: after 2 hours of drug administration
after 2 hours of drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Gerardo di Monza

Investigators

  • Principal Investigator: Federico Villa, MD, Azienda Ospedaliera San Gerardo Monza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 27, 2009

First Submitted That Met QC Criteria

January 27, 2009

First Posted (Estimate)

January 28, 2009

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 19, 2016

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-citerio

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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