AnesthesiaNCT02928172
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia
A study testing qCON-qNOX and BIS in people with Anesthesia and Deep Sedation, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Deep Sedation
- What is being tested?
- qCON-qNOX and BIS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2018to 20 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: 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.
Read more
Objectives:
- 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.
- to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and the qCON index of hypnosis.
- to assess qNOX reliability as a specific indicator of response to nociceptive stimulation.
Read the 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
- Conditions
- Anesthesia, Deep Sedation
- Being tested
- qCON-qNOX, BIS
- Keywords
- q-CON, q-NOX, BIS, Electroencephalograms (EEG), Laryngeal Mask Airway (LMA), Sedation, General Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qCON-qNOXDevice
Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor
BISDevice
Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
| Study group | Role | What they receive |
|---|---|---|
| Depth of Anesthesia | Other | Subjects will have the qCON-qNOX and BIS monitor Receives: Device: qCON-qNOX; Device: BIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movements as Response to Laryngeal Mask Airway (LMA) Insertion
Correlation between qNOX-qNOX and rough clinical signs of insufficient anti-nociception during Laryngeal Mask Airway (LMA) insertion The Laryngeal Mask Airway (LMA) insertion occurs during the induction, lasting an average of 5-10 minutes.
Total number of movements reported for the group as a whole and not per participant.
Measured: Approximately 10 minutes
Number Coughing/Bucking
Coughing/bucking as a response to intraoperative stimuli. The total number of coughing/bucking reported intraoperatively for the group as a whole was recorded.
The intraoperative period lasted approximately 30 min to 3 hours.
Measured: Intraoperative period (30 minutes to 3 hours)
Secondary outcomes (1)
Number of Intraoperative Movements
Movements as a response to intraoperative stimuli. The total number of movements reported intraoperatively for the group as a whole was recorded.
The intraoperative period lasted approximately 30 min to 3 hours.
Measured: Intraoperative period (30 minutes to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start2 Jan 2018
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, M.D., PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928172
- Sponsor's protocol ID
- Pro00043738
- Status last verified
- May 2024
- First submitted
- 4 Oct 2016
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Responses to Nociceptive Stimuli During General Anesthesia Based on Electroencephalographic Signals, an Observational Study
- ClinicalTrials.gov ID
- NCT02928172
- Acronym / sponsor ID
- Pro00043738
- Conditions
- Anesthesia, Deep Sedation
- Keywords
- q-CON, q-NOX, BIS, Electroencephalograms (EEG), Laryngeal Mask Airway (LMA), Sedation, General Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 24 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- to assess the qNOX index of pain/nociception (Quantium Medical, Barcelona, Spain) and the qCON index of hypnosis.
- to assess qNOX reliability as a specific indicator of response to nociceptive stimulation.
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
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depth of Anesthesia | Other | Device: qCON-qNOX, Device: BISSubjects will have the qCON-qNOX and BIS monitor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qCON-qNOXEach subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor | Device | Depth of Anesthesia |
| BISEach subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor | Device | Depth of Anesthesia |
Primary outcome
Movements as Response to Laryngeal Mask Airway (LMA) Insertion
Time frame: Approximately 10 minutes
Correlation between qNOX-qNOX and rough clinical signs of insufficient anti-nociception during Laryngeal Mask Airway (LMA) insertion The Laryngeal Mask Airway (LMA) insertion occurs during the induction, lasting an average of 5-10 minutes. Total number of movements reported for the group as a whole and not per participant.
Number Coughing/Bucking
Time frame: Intraoperative period (30 minutes to 3 hours)
Coughing/bucking as a response to intraoperative stimuli. The total number of coughing/bucking reported intraoperatively for the group as a whole was recorded. The intraoperative period lasted approximately 30 min to 3 hours.
1 secondary outcome
Number of Intraoperative Movements
Time frame: Intraoperative period (30 minutes to 3 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roya Yumul, M.D., PhD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qCON-qNOX and BIS in people with Anesthesia and Deep Sedation, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movements as Response to Laryngeal Mask Airway (LMA) Insertion (time frame: Approximately 10 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.