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EEG Monitoring to Assess Emergence From Neuroanesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00443807
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : April 16, 2008
Information provided by:
University of Manitoba

Brief Summary:
A highly desired result in neuroanesthesia is a prompt, controlled emergence following a neurosurgical procedure. Considerable strides have been made in this direction with volatile anesthetic agents such as sevoflurane or desflurane administered in association with the narcotic remifentanil. It is characteristic that patients will emerge within 5 to 10 minutes of cessation of these agents at the end of a neuroanesthetic. However, there are cases where emergence is delayed, especially after periods of deep anesthesia for i) cerebral protection with temporary clipping of cerebral aneurysms and ii) with microvascular decompression for trigeminal neuralgia. Deep levels of anesthesia are standard for these procedures in the posterior fossa, which utilize motor evoked potentials to assess cranial nerve function. In these cases, EEG monitoring is standard. Using the EEG to monitor emergence to aid its progress makes sense. A monitor which could predict emergence in these patients would be valuable. EEG monitoring engineered to provide this information is now available in the form of the EEGo. This study is designed to test the hypothesis that the EEGo monitor will be superior to the BIS monitor to assess emergence following neuroanesthesia.

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Trigeminal Neuralgia Device: On-line EEG monitoring during neurosurgery Device: EEGo vs BIS Not Applicable

Detailed Description:

Objective: This study is designed to test the hypothesis that the EEGo monitor will be superior to the BIS monitor to assess emergence following neuroanesthesia. The EEGo will be able to more accurately indicate emergence and direct therapy at the end of the operative procedure. The EEGo will be superior because the raw EEG signal is processed using phase delay analysis, with each patient's raw EEG analyzed instead of a proprietary but generic signal processing approach on a linear scale as with the BIS monitor. Phase delay analysis is a standard approach to display nonlinear signals. A highly reproducible signal transition occurs from deep anesthesia to emergence. It is this transition that permits acute assessment of emergence. The ability to process the EEG and display phase delay plots in 50 msec is what makes the EEGo monitor attractive to acutely assess emergence from neuroanesthesia. Accurate emergence will allow better anesthesia management.

This pilot study will be done to assess a nonlinear EEG monitor (EEGo) to direct therapy and predict prompt emergence from neuroanesthesia where EEG monitoring is done in neurosurgical cases. In our centre we routinely monitor the EEG, SSEP and/or MEP during temporary aneurysm clipping and during microvascular decompressive surgery. It is just these cases where emergence can be delayed despite following standard neuroanesthesia techniques. The EEGo processes the standard EEG signal by nonlinear analysis of the raw signal by 3 dimensional phase delay plots. A cascade from a point attractor, periodic attractor, toroidal attractor to a 3-D chaotic attractor occurs from burst suppression to the awake state. These resemble phase transitions and occur rapidly from one state to the next. An analogy is the phase transition that occurs when water changes to ice and vice versa. Monitoring these transitions should permit a rational approach to therapy during anesthesia emergence, better predict emergence, facilitate extubation based on the awake state, allow titration of vasoactive agents during emergence to smooth hemodynamic control and permit more rapid emergence at end procedure. The EEGo will be compared directly in real time to the bispectral (BIS) monitor re goal directed emergence. If efficacy is shown with the EEGo, a more formal comparison to BIS and clinical judgement will be studied.

BIS monitoring can aid emergence in outpatient procedures, both with time to wakening and time in the recovery room. These results also impact on the cost of anesthetic drugs and OR and Recovery Room costs. Work demonstrating accelerated emergence from desflurane with BIS do not highlight the manner in which the BIS directs the emergence. The depth of anesthesia is adjusted to 50 - 60 ABU during maintenance and then emergence is tracked. A specific BIS number to indicate emergence is not suggested. In fact, a correlation between the BIS in the awake state and with movement and eye opening appears poor with the emergence BIS usually being lower than the pre-induction BIS. The BIS may also on occasion be very low during emergence - deemed artifactually so and in this work it is suggested that the raw EEG be observed to aid emergence. It would seem that significant issues relate to intra and interpatient variability with this processed EEG signal. Recent work suggests significant discrepancy of BIS signals between hemispheres and even recording from two sites in the same hemisphere. In addition, BIS correlates poorly with end-tidal desflurane and awake state.

Thus, it would seem that while the BIS can aid management of depth of anesthesia during maintenance, it is not ideally suited to direct a facilitated emergence. In contrast, the EEGo monitor uses nonlinear analysis techniques to provide a visual output related to depth of anesthesia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: A Comparison of the EEGo and BIS Monitors to Assess Emergence From Neuroanesthesia
Study Start Date : August 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: On-line EEG monitoring during neurosurgery
    Comparison of 2 ways of processing the EEG signal
    Other Names:
    • EEGo
    • BIS Vista
  • Device: EEGo vs BIS
    comparison of two processed EEG monitors.

Primary Outcome Measures :
  1. An assessment of quality of emergence - smooth, single cough, multiple coughs will be provided by the neurosurgeon [ Time Frame: Wake up time in OR ]

Secondary Outcome Measures :
  1. Twenty-four hours post surgery a directed survey of patient satisfaction and questioning regarding awareness will be done [ Time Frame: hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All adult patients undergoing neurosurgery where intraoperative EEG monitoring is the standard of care will be approached in the Pre-Anesthetic Clinic for participation.

Exclusion Criteria:

  • Patient refusal
  • a history of asthma requiring routine use of bronchodilators, because the study will use desflurane as the volatile agent
  • pregnancy
  • non-elective aneurysm clipping

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00443807

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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
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Principal Investigator: W. Alan C. Mutch, MD University of Manitoba

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Responsible Party: W. Alan C. Mutch, University of Manitoba Identifier: NCT00443807     History of Changes
Other Study ID Numbers: B2007:008
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: April 16, 2008
Last Verified: April 2008
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases