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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06388408
Other study ID # SufMAST
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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