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Detection of Consciousness by EEG and Auditory Evoked Potentials

Detection of Consciousness by EEG and Auditory Evoked Potentials

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01720615
Enrollment
80
Registered
2012-11-02
Start date
2001-01-31
Completion date
2003-04-30
Last updated
2012-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Electroencephalography/ Drug Effect

Keywords

EEG, AEP, Propofol, Sevoflurane, Remifentanil, General anesthesia

Brief summary

The objective of the present investigation is to analyze EEG and auditory evoked potentials at the transition from consciousness to unconsciousness and vice versa. A set of electroencephalographic and auditory evoked potential parameters should be identified that allows separation of consciousness from unconsciousness (reflected by responsiveness/unresponsiveness to command). The study is based on data of 80 patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol.

Detailed description

During the past years, monitoring of anesthetic effects on the main target of anesthesia, the brain, has gained increasing attention. Monitoring of the spontaneous electroencephalogram (EEG) and of auditory evoked potentials (AEP) has been suggested. Even if EEG and AEP reflect effects of anesthetic drugs, a visual interpretation is not expedient. As a consequence, several processing methods have been suggested that reduce the electroencephalogram to a numerical value. In the current study, a set of EEG- and AEP parameters based on different analysis methods is tested with respect to the parameters ability in separating consciousness (reflected by responsiveness to command) from unconsciousness at the transition between these stages. Therefore data of 80 unpremedicated patients undergoing general anesthesia with remifentanil and either sevoflurane or propofol is used. The study period is from induction of anesthesia until patients follow command after surgery and includes a reduction of the hypnotic agent after tracheal intubation until patients follow command. The isolated forearm technique is applied before muscle relaxants are given to maintain the ability to squeeze hand to command.

Interventions

General anesthesia: Loss of consciousness and standard clinical practice

DRUGSevoflurane / Remifentanil

General anesthesia: Loss of consciousness and standard clinical practice

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* American Society of Anesthesiologists (ASA) physical status 1-2 * Adult patients

Exclusion criteria

* Patients with contraindications to the study drugs * psychiatric or neurologic disease * drug abuse or medication known to affect the central nervous system * pregnancy * indication for rapid sequence induction

Design outcomes

Primary

MeasureTime frame
Changes in EEG- and AEP-parameters during loss- and return of consciousness1 day

Secondary

MeasureTime frame
Impact of muscle activity on EEG- and AEP-parameters1 day
Influence of anesthetics on EEG- and AEP-parameters1 day

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026