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

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.

Study Overview

• Status: Completed
• Conditions: Target Controlled Infusion; Sufentanil; Anesthesia Brain Monitor

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Italy
  • TV
    • Treviso, TV, Italy, 31100
      • Treviso Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol and SufentanilTCI will be recruited

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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	Evaluate if different PSi values at the same Sufentanil concentrations has an impact on postoperative pain	Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours
Analgesia Nociception Index (ANi) values and postoperative nausea and vomiting	Evaluate if different ANi values at the same Sufentanil concentrations has an impact on postoperative nausea and vomiting.	Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values after 24 hours

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Federico Linassi, MD, University of Padova

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SufMAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No