Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- qNOX change
研究概览
简要总结
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)
详细描述
- Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.
- propofol was traditional sedation reagent.
- index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Participants were aged 18-65 years old,
- •American Society of Anesthesiologists (ASA) physical status I, II or III
- •scheduled to have urological surgery(would last longer than 1 h)
- •requiring general anesthesia.
- •Exclusion criteria:
- •refused to participate in this study;
- •Unable to communicate normally because of consciousness alterations;
- •a history of allergy to opioids
- •contraindications to inhalational anesthesia
- •a family history of malignant hyperthermia
- •a history of alcohol or drug abuse
- •received central nervous system-active drugs
- •super obese as defined by a body mass index ≥40 kg/m2
- •conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
- •previous head injury
- •neurologic
- •psychiatric disease
- •any disabling central nervous
- •cerebrovascular disease
- •using psychoactive
- •anti-convulsive medications at the time
- •unstable angina
- •manifested congestive heart failure
- •expected difficulty airway management
排除标准
- 未提供
研究组 & 干预措施
Propofol
5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia.
干预措施: 5mg/kg/h Propofol (Drug)
Propofol & Sevoflurane
2mg/kg/h Propofol & 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia
干预措施: Sevoflurane (Drug)
Propofol & Sevoflurane
2mg/kg/h Propofol & 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia
干预措施: 2 mg/kg/h Propofol (Drug)
结局指标
主要结局
qNOX change
时间窗: during operation
Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.
次要结局
- PACU duration(24 hours)
- PONV difference between two groups(24 hours)
- Post- operative pain difference between two groups(24 hours)