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

NCT ID: NCT02149927

Last Updated: 2014-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anesthesia Drug Effects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Single arm: dose escalation of study medication

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Interventions

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Sevoflurane

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eberhard F Kochs, MD

Role: STUDY_CHAIR

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

Locations

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Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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56012/12

Identifier Type: -

Identifier Source: org_study_id

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