Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
研究概览
简要总结
Analgesia Nociception Index（ANI）which is derived from heart rate variability can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
详细描述
General anesthesia with sevoflurane and remifentanil is widely used in minor surgeries. Monitoring noxious stimulation during general anesthesia is still worth further studies and reaching clinical consensus. Analgesia Nociception Index can be used to detect noxious stimulation during propofol while changing remifentanil concentrations. Previous studies suggest that an ANI≥50 can be useful in detecting sufficient analgesia for patients who cannot self-report pain. The aim of this study is to verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination during sevoflurane while changing remifentanil concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18- 65 years
- •ASA physical status I or II
- •Elective surgery in general anesthesia planned
- •Written informed consent
排除标准
- •Use of CNS-active medication or abuse of alcohol
- •Presents of any neuromuscular or neurologic disease
- •History of cardiac arrhythmia
- •Pregnancy or using a pacemaker
研究组 & 干预措施
Sevoflurane with different site effect concentrations of remifentanil
The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus.
干预措施: Tetanic stimulation (Device)
Sevoflurane with different site effect concentrations of remifentanil
The tetanic stimulus is conducted between laryngeal mask intubation and surgical stimulation, while no other noxious stimuli are presented. The effect site concentration of remifentanil is increased step-by-step via a Target Controlled infusion device to a concentration of 2, 4, 6 ng/ml. At least 5min of the steady-state period is maintained before tetanic stimulus.
干预措施: Skin incision (Procedure)
结局指标
主要结局
To verify the effectiveness of ANI predictability for actual surgical noxious stimuli while satisfying the individual analgesic status by pre-tetanus-induced ANI determination.
时间窗: Change from Baseline ANI that 2 minutes after applied tetanic stilumation
Tetanic stimulations are applied at different effect site concentrations of remifentanil under sevoflurane anesthesia. ANI is range from 0-100. Bigger number means better analgesic level. ANI≥50 is considered to be under adequate analgesia. Tetanic stimulation is a standard tester of nociceptive stimulus. The number of ANI will fall down if the patient is feeling pain.
次要结局
- The ANI predictability for tetanic noxious stimuli(Change from Baseline Systolic Blood Pressure that 2 minutes after applied tetanic stilumation)
- The heart rate predictability for tetanic noxious stimuli(Change from Baseline Heart Rate that 2 minutes after applied tetanic stilumation)
- The Bispectral Index predictability for tetanic noxious stimuli(Change from Baseline Bispectral Index that 2 minutes after applied tetanic stilumation)
研究者
Changwei Wei
Deputy chief physician
Beijing Chao Yang Hospital