AnalgesiaANINCT06351072
Correlation Between qNOX and Analgesia Nociception Index (ANI) Values During General Anesthesia
An observational study of Analgesia, run by University of Padova at 1 site in Italy.
Trial summary
qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia. No trials have compared them, so with this trial authors want to explore the correlations between them. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Analgesia
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 2 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
- 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 model) and remifentanil (Eleveld model)
Who cannot join
- Neurological disease
- Psychiatric disease
- Obesity
- Regional anesthesia performed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between qNOX Values of the CONOX Monitor and Analgesia Nociception Index (ANI) Values During General Anesthesia Conducted With Propofol and Remifentanil TCI
qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.
No trials have compared them, so with this trial authors want to explore the correlations between them.
Read the detailed description
qNOX and ANI are two indexes evaluting the anaglesia conduction during general anesthesia.
Even if the aim is the same (to measure the nociception level) these indexes utilize different algorithm: the qNOX is derived by the electroencephalogrm (EEG), the ANI is derived by heart rate variation.
No trials have compared them, so with this trial authors want to explore the correlations between them, and if altered values of one of them is stronger related to postoperative pain and delirium.
- Conditions
- Analgesia
- Medical subject headings
- Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between qNOX and ANI values
qNOX and ANI values will be compared to check the correspondance in evaluting analgesia level
Measured: qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four and maintenance phase of general anesthesia detected with target controlled inusion will be paired.
Secondary outcomes (2)
Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain
Evaluate if qNOX or ANI values relate to postoperative pain
Measured: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours
Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium
Evaluate if qNOX or ANI values relate to postoperative delirium
Measured: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start2 Apr 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- 15 participants (actual)
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
- NCT06351072
- Sponsor's protocol ID
- NOXANI
- Acronym
- ANI
- Status last verified
- Oct 2024
- First submitted
- 25 Mar 2024
- Last updated
- 24 Oct 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 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between qNOX Values of the CONOX Monitor and Analgesia Nociception Index (ANI) Values During General Anesthesia Conducted With Propofol and Remifentanil TCI
- ClinicalTrials.gov ID
- NCT06351072
- Acronym / sponsor ID
- ANI / NOXANI
- Conditions
- Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 8 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.
qNOX and ANI are two indexes evaluting the analgesia conduction during general anesthesia.
No trials have compared them, so with this trial authors want to explore the correlations between them.
Detailed description
qNOX and ANI are two indexes evaluting the anaglesia conduction during general anesthesia.
Even if the aim is the same (to measure the nociception level) these indexes utilize different algorithm: the qNOX is derived by the electroencephalogrm (EEG), the ANI is derived by heart rate variation.
No trials have compared them, so with this trial authors want to explore the correlations between them, and if altered values of one of them is stronger related to postoperative pain and delirium.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- 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 model) and remifentanil (Eleveld model)
Key exclusion criteria (4 listed)
- Neurological disease
- Psychiatric disease
- Obesity
- Regional anesthesia performed
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 qNOX and ANI values
Time frame: qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four and maintenance phase of general anesthesia detected with target controlled inusion will be paired.
qNOX and ANI values will be compared to check the correspondance in evaluting analgesia level
2 secondary outcomes
Correlation between qNOX from CONOX and Analgesia nocicpetion index (ANI) values and postoperative pain
Time frame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative pain, evalued with NRS score after 24 hours
Correlation between qNOX from CONOX and analgesia nocicpetion index (ANI) values and postoperative delirium
Time frame: qNOX, ANI and remifentanil concentrations recorded during induction, intubation and maintenance phase of general anesthesia will be related to postoperative delirium, evaluated with CAM and 4AT score after 24 hours
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 24 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Analgesia, 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: finished, as of the sponsor's last update on 24 Oct 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?
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?
Correlation between qNOX and ANI values (time frame: qNOX, ANI, pupoillometry values, propofol and remifentanil concentration during induction, intubation, after post-tetanic count at the trend-of-four and maintenance phase of general anesthesia detected with target controlled inusion will be paired.). 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 24 Oct 2024.