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

Sufentanil Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388408
• Other study ID #: SufMAST
• Status: Recruiting
• Start date: May 5, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2024
• Source: University of Padova
• Contact: Federico Linassi, MD
• Phone: 0422322440
• Email: federico.linassi[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sufentanil
• Target Controlled Infusion

Locations

Country	Name	City	State
Italy	Treviso Regional Hospital	Treviso	TV

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia	Evaluate if sufentanil variations during general anesthesia has an impact on the PSi values	PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Primary	Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia	Evaluate if sufentanil variations during general anesthesia has an impact on the EEG power spectrum	EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Primary	Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia	Evaluate if sufentanil 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	Analgesia Nociception Index (ANI) values and postoperative pain	Evaluate if different ANI values at the same Sufentanil concentrations has an impact on postoperative pain	Numeric Rating Scale (NRS) will be evaluated 24 hours after the end of surgery and compared to ANI values after 24 hours
Secondary	Patient State Index (PSi) values and postoperative delirium	Evaluate if different PSi values at the same Sufentanil concentrations has an impact on postoperative pain	4AT test for delirium will be performed 24 hours after the end of surgery and compared to PSi values after 24 hours
Secondary	Analgesia Nociception Index (ANi) values and postoperative delirium	Evaluate if different ANi values at the same Sufentanil concentrations has an impact on postoperative pain	4AT test for delirium will be performed 24 hours after the end of surgery and compared to ANI values after 24 hours