Clinical trial NCT06388408: Effects of Sufentanil Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum During Total Intravenous Anesthesia With Propofol
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia Brain Monitor
Sufentanil
Target Controlled Infusion
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing brast cancer surgery with general anesthesia with Propofol and SufentanilTCI will be recruited

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia
timeFrame: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
measure: Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia
timeFrame: EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
measure: Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia
timeFrame: ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Secondary outcomes:
measure: Analgesia Nociception Index (ANI) values and postoperative pain
timeFrame: 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
measure: Patient State Index (PSi) values and postoperative delirium
timeFrame: Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours
measure: Analgesia Nociception Index (ANi) values and postoperative nausea and vomiting
timeFrame: Nausea and vomiting occurrence will be detected hours atend of surgery and compared to ANI values after 24 hours
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
state: TV
Study officials:
affiliation: University of Padova
name: Federico Linassi, MD
role: PRINCIPAL_INVESTIGATOR
References: