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
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 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Treviso Regional Hospital | Treviso | TV |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
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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