Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/1/2019 |
| Start Date: | January 2, 2018 |
| End Date: | December 2019 |
Monitoring the Responses to Nociceptive Stimuli During General Anesthesia Based on Electroencephalographic Signals, an Observational Study
Hypothesis:
There is a statistically measurable correlation between qNOX and rough clinical signs of
insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion,
skin Incision, LMA removal. It will reduce the problem of anticipating the nociception in
patients undergoing general anesthesia.
Objectives:
1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the
Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery
under sedation and general anesthesia.
2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and
the qCON index of hypnosis.
3. to assess qNOX reliability as a specific indicator of response to nociceptive
stimulation.
There is a statistically measurable correlation between qNOX and rough clinical signs of
insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion,
skin Incision, LMA removal. It will reduce the problem of anticipating the nociception in
patients undergoing general anesthesia.
Objectives:
1. to compare two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the
Bispectral index (BIS™) (Covidien, Boulder CO. USA), in patients undergoing surgery
under sedation and general anesthesia.
2. to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and
the qCON index of hypnosis.
3. to assess qNOX reliability as a specific indicator of response to nociceptive
stimulation.
Monitoring the anti-nociceptive drug effect is useful because a sudden and strong nociceptive
stimulus may result in untoward autonomic responses and muscular reflex movements. Unopposed
stimulation may also 'overrule' a state of stable unconsciousness, with resultant awakening
and awareness. The traditional clinical use of systolic or mean blood pressure is actually
still one of the methods in everyday use for this monitoring purpose. Another cornerstone is
the experience of which drugs and doses are effective in attenuating nociception. Alpiger and
colleagues found that simple end-tidal monitoring of sevoflurane was a better predictor of
nociceptive response than Auditory Evoked Potential.
Thus, monitoring the state of anti-nociception with objective, non-clinical methods is still
in a state of testing and development, without well-documented and proven methods for
consistent 'no-fuss' clinical daily use. Some methods, like those using systolic blood
pressure, are based on the reduced sympathetic response from the Central Nervous System (CNS)
when in a state of drug-induced anti-nociception during concomitant surgical stress. These
include the pulse plethysmogram amplitude, heart rate variability and/or amplitude,
pupillometry, muscle tonus and skin conductance.They all have limitations in interpretation,
as the state of sympathetic tone is strongly influenced by numerous factors, including
hypovolemia, vasopressors, atropine and patient positioning. In addition, sympathetic tone is
very unspecific in the awake or lightly sedated patient, as mood and subjective feelings have
a strong impact.
Attempts are also been made on using the EEG for monitoring of anti-nociception. This
approach has been challenged as difficult, as most of the antinociceptive drugs effects are
in the periphery, the medullary cord or deeper cerebral layers, far from the EEG signals
derived from the frontal cortex. However, EEG is a 'mirror' of what is going on in other
parts of the CNS and peripheral nervous system. One problem is to elucidate how the EEG
signals may be used in a sensitive and specific way to reflect anti-nociception. Concepts
such as response-entropy, Composite Variability Index and BIS variability score have been
tested and launched.
Quantium Medical has an EEG-based algorithm with two outputs: the qCON for unconsciousness
and the qNOX for anti-nociception. This means that calculates and displays two indices. One,
the qCON, is designed to provide information about the depth of the hypnotic state, similar
to that provided by the BIS™ and Sedline™ monitor (Masimo, Irvine CA). The second index, the
qNOX, is designed to provide information about the depth of the antinociceptive state. The
qCON has shown a comparable performance with BIS, and qNOX has proved correlation with rough
clinical signs of insufficient antinociception, such as movements during LMA insertion,
laryngoscopy and tracheal intubation
stimulus may result in untoward autonomic responses and muscular reflex movements. Unopposed
stimulation may also 'overrule' a state of stable unconsciousness, with resultant awakening
and awareness. The traditional clinical use of systolic or mean blood pressure is actually
still one of the methods in everyday use for this monitoring purpose. Another cornerstone is
the experience of which drugs and doses are effective in attenuating nociception. Alpiger and
colleagues found that simple end-tidal monitoring of sevoflurane was a better predictor of
nociceptive response than Auditory Evoked Potential.
Thus, monitoring the state of anti-nociception with objective, non-clinical methods is still
in a state of testing and development, without well-documented and proven methods for
consistent 'no-fuss' clinical daily use. Some methods, like those using systolic blood
pressure, are based on the reduced sympathetic response from the Central Nervous System (CNS)
when in a state of drug-induced anti-nociception during concomitant surgical stress. These
include the pulse plethysmogram amplitude, heart rate variability and/or amplitude,
pupillometry, muscle tonus and skin conductance.They all have limitations in interpretation,
as the state of sympathetic tone is strongly influenced by numerous factors, including
hypovolemia, vasopressors, atropine and patient positioning. In addition, sympathetic tone is
very unspecific in the awake or lightly sedated patient, as mood and subjective feelings have
a strong impact.
Attempts are also been made on using the EEG for monitoring of anti-nociception. This
approach has been challenged as difficult, as most of the antinociceptive drugs effects are
in the periphery, the medullary cord or deeper cerebral layers, far from the EEG signals
derived from the frontal cortex. However, EEG is a 'mirror' of what is going on in other
parts of the CNS and peripheral nervous system. One problem is to elucidate how the EEG
signals may be used in a sensitive and specific way to reflect anti-nociception. Concepts
such as response-entropy, Composite Variability Index and BIS variability score have been
tested and launched.
Quantium Medical has an EEG-based algorithm with two outputs: the qCON for unconsciousness
and the qNOX for anti-nociception. This means that calculates and displays two indices. One,
the qCON, is designed to provide information about the depth of the hypnotic state, similar
to that provided by the BIS™ and Sedline™ monitor (Masimo, Irvine CA). The second index, the
qNOX, is designed to provide information about the depth of the antinociceptive state. The
qCON has shown a comparable performance with BIS, and qNOX has proved correlation with rough
clinical signs of insufficient antinociception, such as movements during LMA insertion,
laryngoscopy and tracheal intubation
Inclusion Criteria:
- Patients scheduled to undergo general surgical procedures with general anesthesia/LMA.
- Willingness and ability to sign an informed consent document.
- 18 - 80 years of age.
- ASA Class I - III adults of either sex
Exclusion Criteria:
- Inability to consent
- Withdrawal criteria
- Electrodes should be changed when patient's skin impedance value exceeds 15 kΩ after
conditioning skin properly. If after two changes of electrodes, impedance remains
above 15 kΩ, patient will be excluded from the present study.
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