Effects of Dexmedetomidine Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum, Analgesia Nociception Index nd Pupillomtry Values During Total Intravenous Anesthesia With Propofol TCI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia
研究概览
简要总结
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.
详细描述
The effects of Dexmedetomidine administered via Target-Controlled Infusion (TCI, Dyck model) on neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil (TCI, Eleveld model) have not yet been investigated.
The authors aim to systematically evaluate the impact of adding Dexmedetomidine on key neuromonitoring parameters commonly used in clinical anesthesia during the maintenance phase of TIVA-TCI. Specifically, the study will assess:
Patient State Index (PSi) as a measure of the hypnotic state;
Electroencephalographic (EEG) power spectrum, to identify changes in cortical activity patterns associated with Dexmedetomidine administration;
Analgesia Nociception Index (ANI), to evaluate potential modifications in the analgesia-nociception balance;
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 80 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 and Rmifntanil (Eleveld model) and Dexmedetomidine (Dyck model)
排除标准
- •Neurological disease
- •Psychiatric disease
- •Regional anesthesia performed
结局指标
主要结局
Effects of Dexmedetomidine on Patient State index (PSi) during stable Propofol - Remifentanil general anesthesia
时间窗: PSi values and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if Dexmedetomidine variations during general anesthesia has an impact on the PSi values
Effects of Dexmedetomidine on Electroencephalogram (EEG) power spectrum during stable Propofol - remifentanil general anesthesia
时间窗: EEG power spectrum and DexmedetomidineTarget Controlled Infusion (TCI) concentrations will be monitored during all the time of surgery
Evaluate if dexmedetomidine variations during general anesthesia has an impact on the EEG power spectrum
Effects of Dexmedetomidine 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 dxmedetomidine 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)
研究者
Federico Linassi
MD, PhD, Principal investigator
University of Padova