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Completed

NCT Number: NCT01720615

Detection of Consciousness by EEG and Auditory Evoked Potentials

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology

Munich, Bavaria, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol / Remifentanil

Drug

General anesthesia: Loss of consciousness and standard clinical practice

Sevoflurane / Remifentanil

Drug

General anesthesia: Loss of consciousness and standard clinical practice

Primary outcomes

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

    Time frame: 1 day

Secondary outcomes

  1. Impact of muscle activity on EEG- and AEP-parameters

    Time frame: 1 day

  2. Influence of anesthetics on EEG- and AEP-parameters

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Important dates

Study start
2001
Primary completion
2001
Study completion
2003
First posted
Nov 2, 2012
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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