EEG Monitoring to Assess Emergence From Neuroanesthesia

This study has been completed.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00443807
First received: March 5, 2007
Last updated: April 15, 2008
Last verified: April 2008
  Purpose

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 Intervention
Cerebral Aneurysm
Trigeminal Neuralgia
Device: On-line EEG monitoring during neurosurgery
Device: EEGo vs BIS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: A Comparison of the EEGo and BIS Monitors to Assess Emergence From Neuroanesthesia

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • An assessment of quality of emergence - smooth, single cough, multiple coughs will be provided by the neurosurgeon [ Time Frame: Wake up time in OR ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Twenty-four hours post surgery a directed survey of patient satisfaction and questioning regarding awareness will be done [ Time Frame: hours ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443807

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

No publications provided

Responsible Party: W. Alan C. Mutch, University of Manitoba
ClinicalTrials.gov Identifier: NCT00443807     History of Changes
Other Study ID Numbers: B2007:008
Study First Received: March 5, 2007
Last Updated: April 15, 2008
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Cranial Nerve Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014