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临床试验/NCT04696016
NCT04696016Unknown不适用

Guiding Sufentanil Administration With Skin Conductance in Mechanically Ventilated Intensive Care Patients

Erasme University Hospital0 个研究点目标入组 30 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Concentration of sufentanil requirements

研究概览

简要总结

Opioid administration in mechanically ventilated patients in the intensive care unit (ICU) is essential to maintaining patient respiratory and hemodynamic stability. Mechanical ventilation is a persistently nociceptive event that can continuously causes discomfort in the trachealy intubated patient. This can lead to patient-ventilator dyssynchrony, tachycardia, hypertension, and their associated complications. Opioids blunt respiratory drive, which facilitates mechanical ventilation, and decrease the sympathetic response to nociception. However, excessive opiate administration is associated with many adverse events, including respiratory depression, delirium, ileus, nausea, and vomiting. Currently, the standard administration in our institution of sufentanil, a potent opiate, consists of continuous infusions of 0.15µg/kg/h to 0.3µg/kg/h.

Mechanically ventilated patients are unable to speak and are often sedated. This greatly impacts the patient's capacity to communicate pain. The use of a nociceptive monitor may be a possible solution. Skin conductance monitoring (Pain Monitor, Med-Storm, Norway), measures the peaks per second of electrical conduction. This non hemodynamic monitor uses skin conduction as a surrogate to nociception (i.e., the patient's unconscious response to a noxious stimulus). It may consequently guide opioid administration in ICU patients towards and avoid the consequences of excessive or inadequate antinociception.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient admitted to the ICU requiring endotracheal intubation, antinociception, and sedation

排除标准

  • Traumatic brain injury
  • use of ketamine, dexmedetomidine, or clonidine
  • pregnancy

结局指标

主要结局

Concentration of sufentanil requirements

时间窗: one day to 2 weeks

Sufentanil requirements (µg/kg/h)

次要结局

  • Concentration of propofol requirements(one day to 2 weeks)
  • Concentration of noradrenaline requirements (concentration of)(one day to 2 weeks)
  • Composite post extubation related complications(one day to 2 weeks)
  • Intubation time(one day to 2 weeks)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

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