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

• ClinicalTrials.gov Identifier: NCT02928172
• Recruitment Status: Enrolling by invitation
• First Posted: October 10, 2016
• Last Update Posted: January 19, 2022
• Sponsor: Cedars-Sinai Medical Center
• Information provided by (Responsible Party): Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia; Deep Sedation	Device: qCON-qNOX; Device: BIS	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Monitoring the Responses to Nociceptive Stimuli During General Anesthesia Based on Electroencephalographic Signals, an Observational Study
• Actual Study Start Date: January 2, 2018
• Estimated Primary Completion Date: December 12, 2022
• Estimated Study Completion Date: December 12, 2022

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. qNOX-qCON, BIS and rough clinical signs [ Time Frame: One day ]
   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

Secondary Outcome Measures :

1. Index of pain (nociception) [ Time Frame: One Day ]
   assessing of the qNOX index of pain (nociception)
2. Indexes of hypnosis [ Time Frame: One Day ]
   comparison of two indexes of hypnosis, the qCON (Quantium Medical, Spain) with the Bispectral index (BIS™)
3. Index of pain-nociception [ Time Frame: One Day ]
   assessing the qCON index of hypnosis

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, California

Cedars Sinai Medical Center

Los Angeles, California, United States, 90048

Sponsors and Collaborators

Cedars-Sinai Medical Center

Investigators

• Principal Investigator: Roya Yumul, M.D., PhD; Cedars-Sinai Medical Center

More Information

• Responsible Party: Roya Yumul, M.D.,PhD., Professor, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT02928172
• Other Study ID Numbers: Pro00043738
• First Posted: October 10, 2016
• Last Update Posted: January 19, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center:

q-CON; q-NOX; BIS; Electroencephalograms (EEG); Laryngeal Mask Airway (LMA); Sedation; General Anesthesia