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

Anesthesia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149927
• Other study ID #: 56012/12
• Status: Completed
• Phase: Phase 0
• First received: April 22, 2014
• Last updated: May 23, 2014
• Start date: June 2013
• Est. completion date: January 2014

Study information

• Verified date: May 2014
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anesthesia
• Drug Effects

Intervention

Drug:
• Sevoflurane

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar	Munich	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 minutes for each condition	No
Secondary	Assessment of the brain network structure during recovery in EEG and fMRI	Identical technical setup than main outcome	10 minutes for each condition	No