Anesthesia Brain MonitoringNCT06349681
Describe Relations Between qCON and qNOX Indicies During Propofol-Remifentanil General Anesthesia
An observational study of Anesthesia Brain Monitoring, run by University of Padova at 1 site in Italy.
Trial summary
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia. It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Anesthesia Brain Monitoring
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2024to 1 Oct 2024
- Phase
- Observational
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI will be recruited
Who may be able to join
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring
Who cannot join
- Neurological disease
- Psychiatric disease
- Obesity
- Locoregional anesthesia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Treviso Regional Hospital
Treviso, TV, 31100
Federico Linassi, federico.linassi@gmail.com
About this study
Official title: Describe Relationship Between qCON and qNOX of the CONOX Monitor During General Anesthesia Perfromed With Propofol and Remifentanil Target Controlled Infusion (TCI)
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.
It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.
Read the detailed description
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.
It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bwtween the 2 indicies, as well as with EMG, Concentration of Propofol (CeP) and Remifentanil (CeR) during Total Intravenous Anesthesia with Target Controlled Infusion (TIVA-TCI).
- Conditions
- Anesthesia Brain Monitoring
- Keywords
- Anesthesia brain Monitoring, TIVA-TCI, CONOX
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between qCON and qNOX
qCON and qNOX values from CONOX monitor will be compared
Measured: CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Secondary outcomes (2)
Correlation between qCON and concentrations of Propofol(CeP)
qCON and CeP values from CONOX monitor and infusion pump will be compared
Measured: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Correlation between qNOX and concentrations of Remifentanil (CeR)
qNOX and CeR values from CONOX monitor and infusion pump will be compared
Measured: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Apr 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Brain MonitoringStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Linassi, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349681
- Sponsor's protocol ID
- CONOXBird
- Status last verified
- Apr 2024
- First submitted
- 24 Mar 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describe Relationship Between qCON and qNOX of the CONOX Monitor During General Anesthesia Perfromed With Propofol and Remifentanil Target Controlled Infusion (TCI)
- ClinicalTrials.gov ID
- NCT06349681
- Acronym / sponsor ID
- CONOXBird
- Conditions
- Anesthesia Brain Monitoring
- Keywords
- Anesthesia brain Monitoring, TIVA-TCI, CONOX
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 5 Apr 2024 (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.
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.
It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bewtween the 2 indicies.
Detailed description
CONOX is a neuromonitoring EEG- device for sedation (qCON) and analgesia (qNOX) monitoring during general anesthesia.
It is unknown on how the indicies can differentiate themselves so aim of this study is to determine the relationship bwtween the 2 indicies, as well as with EMG, Concentration of Propofol (CeP) and Remifentanil (CeR) during Total Intravenous Anesthesia with Target Controlled Infusion (TIVA-TCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI will be recruited
Key inclusion criteria (1 listed)
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model) and CONOX monitoring
Key exclusion criteria (4 listed)
- Neurological disease
- Psychiatric disease
- Obesity
- Locoregional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between qCON and qNOX
Time frame: CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
qCON and qNOX values from CONOX monitor will be compared
2 secondary outcomes
Correlation between qCON and concentrations of Propofol(CeP)
Time frame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Correlation between qNOX and concentrations of Remifentanil (CeR)
Time frame: CONOX and TCI values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia Brain Monitoring
Not yet recruitingObservational study
Cognitive Assessment And Post-Operative Complications After Surgery: Linking Anaesthesia And Risk
Cognitive Impairment, Cognitive Impairment, Mild
RecruitingObservational study
Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison
Propofol, Anesthesia Brain Monitoring
Not yet recruitingObservational study
Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging
Aging, Inflammation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia Brain Monitoring, run by University of Padova at 1 site in Italy.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Apr 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Linassi, MD (0422322440 ext. 0039, federico.linassi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between qCON and qNOX (time frame: CONOX values will be recorded from start of anesthesia to the return of responsiveness at the end of surgery). 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 25 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.