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

NCT06388408 | Completed DMC

• 1 other identifier: SufMAST
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia Brain Monitor; Sufentanil; Target Controlled Infusion

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Neurological disease
• Psychiatric disease
• Obesity
• Regional anesthesia performed

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Treviso Regional Hospital

Treviso, TV, 31100, Italy

Location

Study Officials

• Federico Linassi, MD

  University of Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, prinicpal investigator

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 29, 2024
• Study Start: May 5, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

IT (1)