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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Sufentanil (Gepts model)
排除标准
- •Neurological disease
- •Psychiatric disease
- •Regional anesthesia performed
结局指标
主要结局
Effects of Sufentanil on Patient State index (PSi) during stable Propofol general anesthesia
时间窗: PSi values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the PSi values
Effects of Sufentanil on Electroencephalogram (EEG) power spectrum during stable Propofol general anesthesia
时间窗: EEG power spectrum and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the EEG power spectrum
Effects of Sufentanil on Analgesia Nociception Index (ANI) during stable Propofol general anesthesia
时间窗: ANI values and Sufentanil Target Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if sufentanil variations during general anesthesia has an impact on the ANI values
次要结局
- 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)
研究者
Federico Linassi
MD, prinicpal investigator
University of Padova