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Neural Mechanisms of Sevoflurane Induced Anesthesia: an EEG fMRI Study in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02149927
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:
In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC during unconsciousness have been reported. These results are in accordance to recent electroencephalographic studies observing impaired top-down processing during anesthesia. In this study, simultaneous records of functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in electroencephalogram.

Condition or disease Intervention/treatment Phase
Anesthesia Drug Effects Drug: Sevoflurane Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : June 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Experimental: Sevoflurane
Single arm: dose escalation of study medication
Drug: Sevoflurane



Primary Outcome Measures :
  1. Changes of information processing (entropy) in EEG and functional connectivity (BOLD ICA and small group network architecture) in fMRI during sevoflurane anesthesia at states awake, 2vol%, 3vol% and EEG endpoint burst suppression [ Time Frame: 10 minutes for each condition ]

    Changes of fMRI functional connectivity and of EEG information processing during different levels of sevoflurane anesthesia from wakefulness to deep anesthesia:

    At each anesthetic level at equilibrated states awake, 2vol%, 3vol% and EEG endpoint burst suppression, EEG and fMRI are recorded simultaneously for about 10 minutes. For each level EEG and fMRI connectivity analysis are performed using the recording length of 10 minutes. This results in one outcome parameter for EEG and fMRI connectivity. Furthermore, both modalities are combined resulting in one combined parameter for each level.

    For EEG analysis permutation entropy as a measure of information content in EEG, and symbolic transfer entropy as a measure of directed interaction in EEG are used. fMRI functional connectivity analysis is based on BOLD ICA and on network analysis of the BOLD time series.



Secondary Outcome Measures :
  1. Assessment of the brain network structure during recovery in EEG and fMRI [ Time Frame: 10 minutes for each condition ]
    Identical technical setup than main outcome



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I
  • male
  • age > 18y

Exclusion Criteria:

  • drug abuse
  • history of psychiatric or neurologic diseases
  • amblyacousia, deafness
  • contradictions to the study drug (sevoflurane)
  • implants
  • piercings, tatoos

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): NCT02149927


Locations
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Germany
Klinikum rechts der Isar
Munich, Bayern, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Study Chair: Eberhard F Kochs, MD Klinikum rechts der Isar, Technische Universität München, Munich, Germany

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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02149927     History of Changes
Other Study ID Numbers: 56012/12
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Technische Universität München:
EEG
fMRI
connectivity
sevoflurane

Additional relevant MeSH terms:
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Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs