Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007240

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007240
  •   2015/04/29
  •   2014/04/22
  •   yes
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Secondary IDs

  •   NCT02149927  (ClinicalTrials.gov)
  •   56012/12  (Technische Universität München)
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Health Condition or Problem studied

  •   Anesthesia
  •   Drug Effects
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Interventions/Observational Groups

  •   Drug: Sevoflurane
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   0
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Primary Outcome

- 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.

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Secondary Outcome

- 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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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/06/30
  •   20
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Inclusion Criteria

  •   Male
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

- ASA I

- male

- age > 18y

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Exclusion Criteria

- drug abuse

- history of psychiatric or neurologic diseases

- amblyacousia, deafness

- contradictions to the study drug (sevoflurane)

- implants

- piercings, tatoos

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Addresses

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    • Technische Universität München
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    • Klinikum rechts der Isar, Technische Universität München, Munich, Germany
    • Eberhard F Kochs, MD 
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    • Klinikum rechts der Isar, Technische Universität München, Munich, Germany
    • Eberhard F Kochs, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up complete
  •   2014/01/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.