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CompletedNCT06388408Updated Oct 24, 2024

Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol

An observational study in Anesthesia Brain Monitor, Sufentanil and Target Controlled Infusion, sponsored by University of Padova. Completed at 1 site in Italy. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by University of Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 90 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Anesthesia Brain Monitor
  • Sufentanil
  • Target Controlled Infusion
03

In context

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Women undergoing brast cancer surgery with general anesthesia with Propofol and SufentanilTCI will be recruited

Inclusion criteria

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts model)

Exclusion criteria

Exclusion Criteria:

  • Neurological disease
  • Psychiatric disease
  • Obesity
  • Regional anesthesia performed
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery

  2. 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

    Time frame: EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery

  3. 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

    Time frame: ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery

Secondary outcomes

  1. Analgesia Nociception Index (ANI) values and postoperative pain

    Evaluate if different ANI values at the same Sufentanil concentrations has an impact on 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

  2. Patient State Index (PSi) values and postoperative delirium

    Evaluate if different PSi values at the same Sufentanil concentrations has an impact on postoperative pain

    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

  3. 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.

    Time frame: Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values after 24 hours

07

Study locations

1 site
  • Treviso Regional Hospital
    Treviso, TV 31100, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06388408
Lead sponsor
University of Padova
Responsible party
Federico Linassi (MD, prinicpal investigator, University of Padova) — Principal investigator
First posted
Apr 29, 2024
Start date
May 5, 2024
Primary completion
Sep 15, 2024
Completion
Sep 30, 2024
Last update
Oct 24, 2024

Study contacts

Federico Linassi, MD
principal investigator · University of Padova

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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