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

NCT07259460 | Recruiting DMC

• 1 other identifier: DexMAST
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adjuvants, Anesthesia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Analgesia Nociception Index (ANI) values and 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

  Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

RECRUITING

Central Study Contacts

Federico Linassi, MD, PhD

CONTACT

0422322440; federico.linassi@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal investigator

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

IT (1)