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

NCT02149927 | Completed Early Phase 1

• 1 other identifier: 56012/12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Drug Effects

Keywords

EEG; fMRI; connectivity; sevoflurane

Outcome Measures

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

  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

Secondary Outcomes (1)

• Assessment of the brain network structure during recovery in EEG and fMRI

  10 minutes for each condition

Study Arms (1)

Sevoflurane

EXPERIMENTAL

Single arm: dose escalation of study medication

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Sevoflurane

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I
• male
• age \> 18y

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Eberhard F Kochs, MD

  Klinikum rechts der Isar, Technische Universität München, Munich, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: May 29, 2014
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

DE (1)