Influence of Variations of Systemic Venous Return on Analgesia Nociception Index (ANI) During General Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
研究概览
简要总结
The purpose of this study is to determine whether the value of analgesia nociception index (ANI) is influenced by variations of systemic venous return (cardiac preload) under general anaesthesia.
详细描述
In the context of opioid sparing goal during general anaesthesia, the Analgesia nociception index (ANI) is an analgesia/nociception balance monitoring tool computed from high frequency heart rate variability analysis, and developed by MetroDoloris (Lille, France). Its sensitivity to detect noxious stimulus was studied in several studies. However, its specificity is not established in particular in the presence of factors influencing autonomic nervous system other than analgesia/nociception balance. In the context of anaesthesia, one of the most relevant factor is hypovolemia. This study aims to assess the effect of blood volume variations on ANI under general anaesthesia, independently of analgesia/nociception balance status. Variations of systemic venous return (SVR) (cardiac preload), which reflects blood volume status, will be induced by changes of operating table slope, from head-down tilt (Trendelenburg), with increased SVR, to head-up tilt position, with decreased SVR. Variations of SVR will be attested by changes in the arterial pulse pressure variation, a well-established indice of preload responsiveness in the mechanically ventilated anaesthetized patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •neurosurgical operation requiring invasive monitoring of arterial blood pressure
排除标准
- •pacemaker, arrhythmia
- •chronic medication with beta blocker
- •possible disorder of autonomic nervous system: diabetes, alcoholism, chronic pain
- •anticholinergic drug administration before measures
- •intracranial hypertension
- •no social security coverage
- •pregnancy
研究组 & 干预措施
patients
- noxious stimulus
- change in operating table slope: head-down tilt position
- change in operating table slope: head-up tilt position
干预措施: noxious stimulus (Procedure)
patients
- noxious stimulus
- change in operating table slope: head-down tilt position
- change in operating table slope: head-up tilt position
干预措施: change in operating table slope: head-down tilt position (Procedure)
patients
- noxious stimulus
- change in operating table slope: head-down tilt position
- change in operating table slope: head-up tilt position
干预措施: change in operating table slope: head-up tilt position (Procedure)
结局指标
主要结局
change in ANI between head-down tilt (Trendelenburg) position and head-up tilt position
时间窗: during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions)
Position -20° to +20°
次要结局
- change in ANI between horizontal position and head-down/head up tilt position(during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions))
- change in ANI induced by standardized noxious stimulus (tetanic stimulation)(during a 5sec-tetanic stimulation (measurement for 1-2 min, 2-5 min after initial measurements in basal conditions))
- change in pulse pressure variation between horizontal position and head-down/head up tilt position(during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions))
- change in pulse pressure variation between head-down tilt position and head-up tilt position(during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions))
- variations of low frequency variability of arterial blood pressure(during changes of operating table slope (i.e., for 1-2 min in each condition, 10-15 min after initial measurements in basal conditions))