SEP Changes During Deep Anesthesia

NCT ID: NCT02394002

Last Updated: 2015-03-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-03-31

Brief Summary

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The relation between burst and suppression periods in transcranial and direct cortical recorded EEG with cortical amplitudes median nerve somatosensory evoked potentials is studied.

60 patients are included in this study: 15 patients undergoing brain tumor surgery, 15 spine surgery (University Hospital Düsseldorf) and 30 patients during general surgical procedures (Helios Klinikum Wuppertal).

Detailed Description

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Conditions

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Somatosensory Evoked Potentials, and Electroencephalography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Brain surgery

Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Spine surgery

Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

General surgery

Somatosensory evoked potentials in relation to anasthesia (Propofol bolus) induced burst and suppression periods in electroencephalography

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Interventions

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Propofol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Location Helios Klinikum Wuppertal: neurological healthy patients, which undergo an elective surgery under general anaesthesia
* Location Department of Neurosurgery, University Hospital Düsseldorf: all patients with intracranial interventions and the possibility to place a stripe electrode without complications on cortex (it is decided by the surgeon while surgery because of the situs and tumorlocation)

Exclusion Criteria

* periodical consumption of drugs and pharmaceuticals which influence cortical excitability
* intraoperative contraindication for required depth of anaesthesia
* neurological pre-existing illness
* advanced hepatic insufficiency
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Anaesthesiology, Heinrich Heine University

UNKNOWN

Sponsor Role collaborator

Department of Anesthesiology, Helios Klinikukm Wuppertal

UNKNOWN

Sponsor Role collaborator

Andrea Szelenyi

OTHER

Sponsor Role lead

Responsible Party

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Andrea Szelenyi

Prof. Dr. med. Andrea Szelényi

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrea Szelényi, Prof.

Role: PRINCIPAL_INVESTIGATOR

Neurosurgical Clinic, Heinrich Heine University

Locations

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Neurosurgical Clinic

Düsseldorf, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Andrea Szelényi, Prof.

Role: CONTACT

+49 211 8117646

Facility Contacts

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Andrea Szelényi, Prof.

Role: primary

+49 211 8117646

Sebastian Braun, Dr.

Role: backup

+49 211 8107425

Other Identifiers

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2013071151

Identifier Type: -

Identifier Source: org_study_id

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