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

Effects of Sufentanil Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum and Analgesia Nociception Index During Total Intravenous Anesthesia With Propofol TCI

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06388408

Enrollment

Registered

2024-04-29

Start date

2024-05-05

Completion date

2024-09-30

Last updated

2024-10-24

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

Conditions

Anesthesia Brain Monitor, Sufentanil, Target Controlled Infusion

Brief summary

Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol 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) nad pupillometry values during maintenance durin TIVA-TCI with Propofol and Sufentanil.

Detailed description

Sufentanil Target Controlled infusion (TCI, Gepts model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol 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 and Sufentanil.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts model)

Exclusion criteria

* Neurological disease * Psychiatric disease * Obesity * Regional anesthesia performed

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	Evaluate if different ANI values at the same Sufentanil concentrations has an impact on postoperative pain
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	Evaluate if different PSi values at the same Sufentanil concentrations has an impact on postoperative pain
Analgesia Nociception Index (ANi) values and postoperative nausea and vomiting	Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values after 24 hours	Evaluate if different ANi values at the same Sufentanil concentrations has an impact on postoperative nausea and vomiting.

Countries

Italy

Outcome results