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Completed

NCT Number: NCT02149927

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

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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Key information

Conditions

Anesthesia Drug Effects

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sevoflurane

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
May 29, 2014
Registry last updated
May 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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