Anesthesia Brain MonitorNCT06388408
Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol
An observational study of Anesthesia Brain Monitor and Sufentanil, run by University of Padova at 1 site in Italy.
Trial summary
Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Anesthesia Brain Monitor, Sufentanil, Target Controlled Infusion
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 5 May 2024to 30 Sep 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 SufentanilTCI will be recruited
Who may be able to join
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts 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: Effects of Sufentanil Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum and Analgesia Nociception Index During Total Intravenous Anesthesia With Propofol TCI
Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.
Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil.
Read the detailed description
Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.
Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) and pupillometry values during maintenance during TIVA-TCI with Propofol and Sufentanil.
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia
Evaluate if sufentanil variations during general anesthesia has an impact on the PSi values
Measured: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia
Evaluate if sufentanil variations during general anesthesia has an impact on the EEG power spectrum
Measured: EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia
Evaluate if sufentanil variations during general anesthesia has an impact on the ANI values
Measured: ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Secondary outcomes (3)
Analgesia Nociception Index (ANI) values and postoperative pain
Evaluate if different ANI values at the same Sufentanil concentrations has an impact on postoperative pain
Measured: Numeric Rating Scale (NRS) will be evaluated after the end of surgery and 24 hours after the end of surgery and compared to ANI values after 24 hours
Patient State Index (PSi) values and postoperative delirium
Evaluate if different PSi values at the same Sufentanil concentrations has an impact on postoperative pain
Measured: Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours
Analgesia Nociception Index (ANi) values and postoperative nausea and vomiting
Evaluate if different ANi values at the same Sufentanil concentrations has an impact on postoperative nausea and vomiting.
Measured: Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values 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 posted29 Apr 2024
- Study start5 May 2024
- Primary completion15 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Brain MonitorStudies 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
- 20 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
- Investigators
- Federico Linassi, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388408
- Sponsor's protocol ID
- SufMAST
- Status last verified
- Oct 2024
- First submitted
- 24 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
- Effects of Sufentanil Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum and Analgesia Nociception Index During Total Intravenous Anesthesia With Propofol TCI
- ClinicalTrials.gov ID
- NCT06388408
- Acronym / sponsor ID
- SufMAST
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 5 May 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 29 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.
Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.
Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil.
Detailed description
Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol TCI (Eleveld model) has not been investigate yet.
Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) and pupillometry values during maintenance during TIVA-TCI with Propofol and Sufentanil.
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 SufentanilTCI will be recruited
Key inclusion criteria (1 listed)
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts 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
Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia
Time frame: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the PSi values
Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia
Time frame: EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the EEG power spectrum
Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia
Time frame: ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the ANI values
3 secondary outcomes
Analgesia Nociception Index (ANI) values and postoperative pain
Time frame: Numeric Rating Scale (NRS) will be evaluated after the end of surgery and 24 hours after the end of surgery and compared to ANI values after 24 hours
Patient State Index (PSi) values and postoperative delirium
Time frame: Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours
Analgesia Nociception Index (ANi) values and postoperative nausea and vomiting
Time frame: Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values 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
Related trials for Anesthesia Brain Monitor
Not yet recruitingPhase 4
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General Anesthesia-Induced Altered Consciousness
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Elucidating the Neural Correlates of Anesthesia-induced Unconsciousness in Neonates
Anesthesia Brain Monitor, Anesthesia
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Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging
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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.
Federico Linassi, MD principal investigator
University of Padova
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 Monitor and Sufentanil, 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?
Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia (time frame: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery). The study lists 3 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 24 Oct 2024.