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

ConditionAdjuvants, Anesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorUniversity of Padova

About this trial

Dexmedetomidine Target Controlled infusion (TCI, Dyck model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil 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, Remifentanil and Dexmedetomidine.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergo general anaesthesia with Targeted Controlled Infusion of Propofol and Rmifntanil (Eleveld model) and Dexmedetomidine (Dyck model)

Disqualifiers

Neurological disease

Psychiatric disease

Obesity

Regional anesthesia performed

Trial population

Women undergoing brast cancer surgery with general anesthesia with Propofol, remifentanil and Dexmedetomidine TCI will be recruited

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia

Evaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values

Time frame
PSi values and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
2

Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesia

Evaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum

Time frame
EEG power spectrum and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
3

Effects of Dexmedetomidine on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia

Evaluate if dxmedetomidine variations during general anesthesia has an impact on the ANI values

Time frame
ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery

Secondary outcomes

1

Analgesia Nociception Index (ANI) values and postoperative pain

Evaluate if different ANI values at the same dexmedetomidine concentrations has an impact on postoperative pain

Time frame
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
2

Patient State Index (PSi) values and postoperative delirium

Evaluate if different PSi values at the same dexmedetomidine concentrations has an impact on postoperative delirium

Time frame
Confusion assessment method (CAM) test for delirium will be performed after the end of surgery and compared to PSi values after 24 hours

Other outcomes

Sponsors and contacts

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University of Padova

Lead sponsor

Source ClinicalTrials.gov
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