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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adjuvants, Anesthesia

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Federico Linassi, MD, PhD; Phone Number: 0422322440; Email: federico.linassi@gmail.com

Study Locations

• Italy
  • TV
    • Treviso, TV, Italy, 31100
      • Recruiting
      • Treviso Regional Hospital
      • Contact: Federico Linassi; Email: federico.linassi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol, remifentanil and Dexmedetomidine TCI will be recruited

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia	Evaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values	PSi values and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesia	Evaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum	EEG power spectrum and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Effects of Dexmedetomidine on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia	Evaluate if dxmedetomidine variations during general anesthesia has an impact on the ANI values	ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia Nociception Index (ANI) values and postoperative pain	Evaluate if different ANI values at the same dexmedetomidine concentrations has an impact on postoperative pain	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 dexmedetomidine concentrations has an impact on postoperative delirium	Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours

Collaborators and Investigators

• Sponsor: University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DexMAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No