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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07259460
Enrollment
60
Registered
2025-12-02
Start date
2025-12-01
Completion date
2026-07-30
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjuvants, Anesthesia

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.

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.

Interventions

None listed

Sponsors

University of Padova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesiaPSi values and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgeryEvaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values
Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesiaEEG power spectrum and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgeryEvaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum
Effects of Dexmedetomidine on Analgesia Nociception Index (ANI) during stable Propofol general anesthesiaANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgeryEvaluate if dxmedetomidine variations during general anesthesia has an impact on the ANI values

Secondary

MeasureTime frameDescription
Analgesia Nociception Index (ANI) values and postoperative painNumeric 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 hoursEvaluate if different ANI values at the same dexmedetomidine concentrations has an impact on postoperative pain
Patient State Index (PSi) values and postoperative deliriumConfusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hoursEvaluate if different PSi values at the same dexmedetomidine concentrations has an impact on postoperative delirium

Countries

Italy

Contacts

Primary ContactFederico Linassi, MD, PhD
federico.linassi@gmail.com0422322440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026