Detection of Nociceptive Stimulation and Anesthesia State by Equivalent Minimum Alveolar Concentration (eMAC) During Anesthesia With Varying Propofol and Remifentanil Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Prediction probability of eMAC
研究概览
简要总结
The aim of this study is to verify the accuracy of eMAC compared to Bispectral Index (BIS) for depth and nociceptive stimulation monitoring of anesthesia during general anesthesia.
详细描述
eMAC is a new index based on response surface model for evaluating anesthesia state and anti-nociceptive stimulation levels. To valid it's clinical accuracy, a protocol was designed.
Patients will be allocated to receive a specific effect-site concentration of remifentanil and propofol during tonic electrical stimulation (5s, 50mA) and intubation. The concentration combinations include the electrical stimulation combination (effector chamber concentration random: remifentanil 0-3 ng/ml, propofol 3-5 ug/ml) and the intubation combination (effector chamber concentration random: remifentanil 3-5 ng/ml, propofol 3-5 ug/ml). All combinations were decided before operation. Every combination had a 5 min equilibration period, and the vital signs (Heart Rate, Blood pressure, any body movement) and BIS, eMAC will be recorded before and after the electrical stimulation and intubation. After this period, patients will be randomly allocated to receive an intravenous anesthesia or intravenous combined anesthesia, and regular anesthesia is executed. This study only records vital signs and BIS, eMAC during maintenance period of perioperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective surgery under general anesthesia;
- •Patients with ASA rating I~III;
- •The age of the patient is more than 18 years old;
- •The informed consent has been signed;
排除标准
- •Patients who are participating in other trials;
- •Patients with cognitive impairment, mental illness or taking psychotropic drugs within three months;
- •Patients with a history of stroke;
- •Patients with a history of alcoholism (long-term drinking more than 5 years, daily white wine consumption ≥ 50ml);
- •Pregnant women;
- •Patients with BMI>30;
- •Patients and family members who are unwilling to participate after understanding the research content;
- •According to the evaluation of the researcher, the actual condition is not suitable for the patients participating in this trial.
研究组 & 干预措施
Group 1 BIS under tetanic electrical stimulation
During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: Propofol (Drug)
Group 1 BIS under tetanic electrical stimulation
During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: Low Remifentanil (Drug)
Group 1 BIS under tetanic electrical stimulation
During tetanic electrical stimulation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: tetanic electrical stimulation (Procedure)
Group 2 eMAC under tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: Propofol (Drug)
Group 2 eMAC under tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: Low Remifentanil (Drug)
Group 2 eMAC under tetanic electrical stimulation
During tetanic electrical stimulation or intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:0-3ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: tetanic electrical stimulation (Procedure)
Group 3 BIS under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: Propofol (Drug)
Group 3 BIS under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: Heigh Remifentanil (Drug)
Group 3 BIS under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's BIS.
干预措施: Intubation (Procedure)
Group 4 eMAC under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: Propofol (Drug)
Group 4 eMAC under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: Heigh Remifentanil (Drug)
Group 4 eMAC under intubation
During intubation, and with propofol(random:3-5ug/ml) and remifentanil(random:3-5ng/ml), the response (body movement or hemodynamic change) was observed, and recorded it's eMAC.
干预措施: Intubation (Procedure)
结局指标
主要结局
Prediction probability of eMAC
时间窗: 1 year
Prediction probability is an index(range:0-1) to describe the concordance between continuous measures and discrete scores. Prediction probability bettween eMAC and the lable of response was calculated.
次要结局
- Prediction probability of BIS(1 year)
研究者
Zhang Haopeng
Associate professor
Xijing Hospital