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Completed

NCT Number: NCT06388408

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

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.

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Key information

Conditions

Anesthesia Brain Monitor Sufentanil Target Controlled Infusion

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Treviso Regional Hospital

Treviso, TV, 31100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

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

  2. 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

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

  3. 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

    Evaluate if different ANi values at the same Sufentanil concentrations has an impact on postoperative nausea and vomiting.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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