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临床试验/NCT03978819
NCT03978819已完成不适用

Ability of the Analgesia Nociception Index Monitor to Distinguish Between Excessive Analgesia and Inadvertent Parasympathetic Nerve Stimulation During Surgery of Large Cerebellopontine Angle Tumours

Association de Developpement de la Neuroanesthesie Reanimation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Differences in instantaneous ANI (ANIi) values during bradycardia versus ANIi values when Remifentanil effect size concentration >6ng/mL

研究概览

简要总结

Surgery of large cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression of the pons exposes the patient to inadvertent parasympathetic nerve stimulation (IPNS) leading to bradycardia and asystole.

The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. ANI >80 generally denotes excessive analgesia (EA). The main objective of this study was to determine whether ANI values for IPNS are different or the same as ANI values for EA. This study also aims at calculating the number of patients with IPNS and EA during surgery of large CPA tumours.

详细描述

Bradycardia and asystole are potential life threatning complications during surgery of large cerebellopontine angle (CPA) tumors (>2 x 2 cm diameter), with compression of the pons.The incidence of such complications are unknown. One of the plausible mechanisms is inadvertent parasympathetic nerve stimulation (IPNS) due to the proximity of this cranial nerve to the CPA tumor. Monitoring parasympathetic nerve activity may provide further insight to the implication of this cranial nerve in the cardiac complications observed during surgery of large CPA tumors. The analgesia nociception index (ANI) monitor assesses the balance between analgesia and nociception through the detection of parasympathetic tone. Despite the abundant clinical reports about this index, to the knowledge of the investigators, only a few studies have been published in the neurological setting. Moreover, there are no data reporting the parasympathetic profile (measured by the ANI monitor) in situations of IPNS and EA. Are these profiles the same or different? Such is the main question this study thrives to answer. Understanding the behavior of parasympathetic nerve activity in this context could help provide the appropriate management strategy.

In order to answer this question, participants undergoing elective large CPA tumor surgery were included in this prospective observational study. Standard cardiorespiratory monitoring including heart rate (HR) was done. Target-controlled anesthesia with Propofol and Remifentanil was guided by a bispectral index of 30-40 and an ANI of 50-70 respectively. Data was continuously recorded with event markers at the onset of bradycardia (HR < 45 bpm), asystole and the coincidence of ANI > 80 with Remifentanil site effect > 6 ng.ml-1 (defined as excessive analgesia).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •patients undergoing elective surgery of large cerebellopontine angle tumors

排除标准

  • •age below 18yr
  • •arrhythmia
  • •preoperative use of vagolytics, β-blockers and clonidine.

结局指标

主要结局

Differences in instantaneous ANI (ANIi) values during bradycardia versus ANIi values when Remifentanil effect size concentration >6ng/mL

时间窗: ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)

ANI, HR and Remifentanil effect site concentration were continuously recorded with event markers on the ANI monitor at the onset of bradycardia (HR\<45 bpm) or Remifentanil effect site concentration\>6ng/mL

Differences in the area under the ROC curves between ANI values for IPNS and EA analgesia

时间窗: ANIi values recorded at Day 1 only during surgery (duration: 4-6 hours)

ROC curves were built at different ANIi for IPNS or EA

次要结局

  • Percentages of IPNS and EA cases(Cases observed at Day 1 only during surgery (duration: 4-6 hours))

研究者

发起方
Association de Developpement de la Neuroanesthesie Reanimation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Sesay

Principal Investigator

Association de Developpement de la Neuroanesthesie Reanimation

研究点 (1)

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