General AnesthesiaBis-qCON-IVNCT03753217
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Intravenous Anesthesia
A study testing qCON Monitor in people with General Anesthesia, run by Hopital Foch at 1 site in France.
Trial summary
Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General Anesthesia
- What is being tested?
- qCON Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2018to 21 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years,
- Patients affiliated to a national insurance scheme or benefiting from such a program,
- Patients having given their written consent,
- Patients that must benefit from a general anesthesia by intravenous drugs (propofol and remifentanil),
- For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number.
Who cannot join
- Pregnant or breast-feeding Women,
- Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,
- Patients having a contraindication to Propofol and/or to Remifentanil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.
Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.
- Conditions
- General Anesthesia
- Being tested
- qCON Monitor
- Keywords
- Anesthesia Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qCON MonitorDevice
supervision by qCON monitor of the depth of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| qCON Monitor | Experimental | Simultaneous measurement of BIS and qCON Receives: Device: qCON Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
qCON monitoring during maintenance of anesthesia
Measurement of qCON values during maintenance of anesthesia
Measured: Up to 10 hours
BIS monitoring during maintenance of anesthesia
Measurement of BIS values during maintenance of anesthesia
Measured: Up to 10 hours
Secondary outcomes (10)
qCON monitoring during induction of anesthesia
Measurement of qCON values during induction of anesthesia
Measured: One day
BIS monitoring during induction of anesthesia
Measurement of BIS values during induction of anesthesia
Measured: One day
qCON monitoring during recovery of anesthesia
Measurement of qCON values during recovery of anesthesia
Measured: One day
BIS monitoring during recovery of anesthesia
Measurement of BIS values during recovery of anesthesia
Measured: One day
Burst Suppression ratio retrieved by qCON monitoring
Measurement of Burst Suppression ratio values during anesthesia
Measured: One day
Burst Suppression ratio retrieved by BIS monitoring
Measurement of Burst Suppression ratio values during anesthesia
Measured: One day
qNOX monitoring during anesthesia
Measurement of qNOX values during anesthesia
Measured: One day
Periods of loss of signal of qCON
Measurement of qCON values during anesthesia
Measured: One day
Periods of loss of signal of BIS
Measurement of BIS values during anesthesia
Measured: One day
Intraoperative memorising
Questionnaire for assessment of memorising of surgery by the patient
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start4 Dec 2018
- Primary completion21 Dec 2018
- Study completion21 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD PhD, Study director, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753217
- Sponsor's protocol ID
- 2016/57
- Acronym
- Bis-qCON-IV
- Status last verified
- Aug 2018
- First submitted
- 22 Nov 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.
- ClinicalTrials.gov ID
- NCT03753217
- Acronym / sponsor ID
- Bis-qCON-IV / 2016/57
- Conditions
- General Anesthesia
- Keywords
- Anesthesia Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 21 Dec 2018 (actual)
- Study completion
- 21 Dec 2018 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| qCON Monitor | Experimental | Device: qCON MonitorSimultaneous measurement of BIS and qCON |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients above 18 years,
- Patients affiliated to a national insurance scheme or benefiting from such a program,
- Patients having given their written consent,
- Patients that must benefit from a general anesthesia by intravenous drugs (propofol and remifentanil),
- For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number.
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding Women,
- Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,
- Patients having a contraindication to Propofol and/or to Remifentanil.
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 Monitorsupervision by qCON monitor of the depth of anesthesia | Device | qCON Monitor |
Primary outcome
qCON monitoring during maintenance of anesthesia
Time frame: Up to 10 hours
Measurement of qCON values during maintenance of anesthesia
BIS monitoring during maintenance of anesthesia
Time frame: Up to 10 hours
Measurement of BIS values during maintenance of anesthesia
10 secondary outcomes
qCON monitoring during induction of anesthesia
Time frame: One day
BIS monitoring during induction of anesthesia
Time frame: One day
qCON monitoring during recovery of anesthesia
Time frame: One day
BIS monitoring during recovery of anesthesia
Time frame: One day
Burst Suppression ratio retrieved by qCON monitoring
Time frame: One day
Burst Suppression ratio retrieved by BIS monitoring
Time frame: One day
qNOX monitoring during anesthesia
Time frame: One day
Periods of loss of signal of qCON
Time frame: One day
Periods of loss of signal of BIS
Time frame: One day
Intraoperative memorising
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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.
Marc Fischler, MD PhD study director
Hopital Foch
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 Monitor in people with General Anesthesia, run by Hopital Foch at 1 site in France.
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 5 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 15 Feb 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
qCON monitoring during maintenance of anesthesia (time frame: Up to 10 hours). 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 15 Feb 2019.