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Clinical Trials/NCT01720615
NCT01720615CompletedPhase 4

Detection of Consciousness by EEG and Auditory Evoked Potentials

Technical University of Munich1 site in 1 country80 target enrollmentStarted: January 2001Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Changes in EEG- and AEP-parameters during loss- and return of consciousness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Sex
All
Accepts 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

Arms & Interventions

Propofol or Sevoflurane

No Intervention

General anesthesia

Intervention: Propofol / Remifentanil (Drug)

Propofol or Sevoflurane

No Intervention

General anesthesia

Intervention: Sevoflurane / Remifentanil (Drug)

Outcomes

Primary Outcomes

Changes in EEG- and AEP-parameters during loss- and return of consciousness

Time Frame: 1 day

Secondary Outcomes

  • Impact of muscle activity on EEG- and AEP-parameters(1 day)
  • Influence of anesthetics on EEG- and AEP-parameters(1 day)

Investigators

Sponsor
Technical University of Munich
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gerhard Schneider

Dr. med.

Technical University of Munich

Study Sites (1)

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