Treviso Regional Hospital
Treviso, TV, 31100, Italy
Location status: Recruiting
NCT Number: NCT07259460
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.
Interested in participating?
Request Info18 year–80 year
Female
Observational
Treviso, TV, 31100, Italy
Location status: Recruiting
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
University of Padova
Other
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
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