跳至主要内容
临床试验/NCT03103698
NCT03103698已完成不适用

The Interest of the ANI in the Monitoring of Peroperative Analgesia in Bariatric Surgery: a Randomized Single Blind Study.

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2016年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
The amount of morphine used per operatively in the two groups

研究概览

简要总结

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice.

详细描述

The intraoperative assessment of analgesia remains problematic and no analgesia monitor is used in routine practice. Currently, this assessment is based on hemodynamic changes, although hypertension or tachycardia is neither sensitive nor specific. An overdose in opioids exposes to many side effects ranging from respiratory depression to phenomena of post-operative hyperalgesia. Conversely, an under-dosage in opioids is at the origin of a nociceptive stress whose neurovegetative and hormonal response can aggravate post-operative morbidity or promote the occurrence of implicit memorization.

Nociceptive influx can not be detected directly. However, its ascent to the somesthetic area of the cerebral cortex leads to physiological reactions that can be evaluated. In particular, there are numerous anatomical and functional interactions between the autonomic nervous system and the nociceptive tract in the brain stem. These interactions are mainly at the level of the gray periqueducal substance, the rostral ventro-lateral bulbous region, the solitary tract nucleus and the hypothalamus. The nociceptive influx thus leads to changes in the activity of the ANS. The study of changes in the ANS would therefore be a method of assessing the intensity of the nociceptive influx.

This objective method can be used in the non-communicating or unconscious patient to evaluate the pain and to adapt the analgesic treatment to the best.

Obese patients who receive surgical management often have comorbidities such as restrictive syndrome, or obstructive sleep apnea syndrome. They thus represent a target of choice in perioperative analgesic optimization in order to avoid respiratory complications that may be related to over or under assay of morphine such as atelectasis, alveolar hypoventilation.

It is hypothesized that this device is more effective for the intraoperative evaluation of analgesia than the usual method based on hemodynamic changes in intraoperatively anesthetized patients for bariatric 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
None

入排标准

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

入选标准

  • Major Patient Age ≥ 18 years
  • Adult patients candidate for planned surgery with BMI>
  • Affiliation to social security.
  • Patients who were clearly informed and signed consent.

排除标准

  • Patient with a heart rhythm disorder.
  • Respiratory rate less than 9 cycles / min.
  • Irregular spontaneous ventilation.
  • Perioperative use of a drug acting on the sinus node (eg atropine, etc.)
  • History of neuropathic pain.
  • Patient under morphine until the day before surgery.
  • Patients under guardianship or curatorship or deprived of liberty

结局指标

主要结局

The amount of morphine used per operatively in the two groups

时间窗: 1 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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