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NCT Number: NCT07259460

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

Dexmedetomidine Target Controlled infusion (TCI, Dyck model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil 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, Remifentanil and Dexmedetomidine.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location status: Recruiting

Location contact

Federico Linassi

CONTACT

[email protected]

About this study

The effects of Dexmedetomidine administered via Target-Controlled Infusion (TCI, Dyck model) on neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil (TCI, Eleveld model) have not yet been investigated.

The authors aim to systematically evaluate the impact of adding Dexmedetomidine on key neuromonitoring parameters commonly used in clinical anesthesia during the maintenance phase of TIVA-TCI. Specifically, the study will assess:

Patient State Index (PSi) as a measure of the hypnotic state;

Electroencephalographic (EEG) power spectrum, to identify changes in cortical activity patterns associated with Dexmedetomidine administration;

Analgesia Nociception Index (ANI), to evaluate potential modifications in the analgesia-nociception balance;

Pupillometry, to quantify autonomic and pupillary responses to stimuli.

This investigation aims to determine whether the addition of Dexmedetomidine using a TCI approach produces predictable and clinically relevant alterations in neurophysiological monitoring during anesthesia with Propofol and Remifentanil. Ultimately, the study seeks to support more precise drug titration and enhance patient safety.

Who can participate

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

Inclusion criteria

  • Undergo general anaesthesia with Targeted Controlled Infusion of Propofol and Rmifntanil (Eleveld model) and Dexmedetomidine (Dyck model)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia

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

    Evaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values

  2. Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesia

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

    Evaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum

  3. Effects of Dexmedetomidine 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 dxmedetomidine 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 dexmedetomidine 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 dexmedetomidine concentrations has an impact on postoperative delirium

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Linassi, MD, PhD

CONTACT

[email protected]

0422322440

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Effects of Dexmedetomidine Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum, Analgesia Nociception Index nd Pupillomtry Values During Total Intravenous Anesthesia With Propofol TCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Dec 23, 2025

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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