Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Deep Sedation
• Intervention / Treatment: Device: qCON-qNOX; Device: BIS

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Depth of Anesthesia; Subjects will have the qCON-qNOX and BIS monitor	Device: qCON-qNOX; Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor; Device: BIS; Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
qNOX-qCON, BIS and rough clinical signs	correlation between qNOX-qNOX, BIS and rough clinical signs of insufficient anti-nociception such as movements during Laryngeal Mask Airway (LMA) insertion, skin Incision, LMA removal	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index of pain (nociception)	assessing of the qNOX index of pain (nociception)	One Day
Indexes of hypnosis	comparison of two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the Bispectral index (BIS™)	One Day
Index of pain-nociception	assessing the qCON index of hypnosis	One Day

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): February 20, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 7, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 20, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Sedation; General Anesthesia; BIS; q-CON; q-NOX; Electroencephalograms (EEG); Laryngeal Mask Airway (LMA)
• Other Study ID Numbers: Pro00043738

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes