Effect of Intraoperative Nociception Control Based on Analgesia Nociception Index (ANI) Monitoring on Stress Response During Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
研究概览
简要总结
The "Analgesia Nociception Index" (ANI; MetroDoloris Medical Systems, Lille, France), derived from an electrocardiogram (ECG) trace, has been proposed as a noninvasive guide to analgesia. The ANI monitor calculates HR variation with respiration, a response mediated primarily by changes in the parasympathetic nervous system (PNS) stimulation to the sinoatrial node of the heart. The aim of this study is to determine the relation between ANI monitor values and serum catecholamine levels. We will compare the serum catecholamine (norepinephrine, epinephrine) levels of conventional nociception control group and ANI-monitor guided nociception control group at the end of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The subject will be randomly allocated to 2 groups using computer-generated randomization method. Anesthesiologists will not be blinded to the groups because of organizational reasons.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients undergoing total laparoscopic hysterectomy under general anesthesia (American society of anesthesiologists classification 1~3)
排除标准
- •endometriosis
- •AP diameter of uterus > 12cm
- •cognitive disorder
- •arrhythmia, pacemaker
- •chronic opioid use
- •diseases affecting autoimmune system (immune disease, diabetic neuropathy)
- •use of medications affecting ANI monitor (antimuscarinics, alpha-agonist, beta blocker)
- •illiteracy, foreigner
结局指标
主要结局
Serum catecholamine (norepinephrine, epinephrine) level at the end of surgery
时间窗: at the end of surgery (skin closure)
Blood samples for serum catecholamine (norepinephrine, epinephrine) will be drawn at the end of surgery and 1 hour after the end of surgery..
次要结局
- hormone level (cortisol, adrenocorticotropic hormone)(at the end of surgery (skin closure) and 1 hour after the end of surgery)
- plasma inflammatory markers (IL-6, IL-10, HMGB1)(at the end of surgery (skin closure) and 1 hour after the end of surgery)
- serum catecholamine (norepinephrine, epinephrine) level(1 hour after the surgery)