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Recruiting NCT07259460

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

— Observational Adjuvants, Anesthesia

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What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Adjuvants, Anesthesia. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Primary outcome measures

  • 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]
  • 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]
  • 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]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Treviso Regional Hospital — Treviso

Identifiers

NCT: NCT07259460 · DexMAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗