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临床试验/NCT04788732
NCT04788732Unknown不适用

Heart Rate Variability as Tool for Quantification of General Anesthesia Depth in Patients

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
To create a new Depth of Anesthesia (DoA) Score based on Heart Rate Variability indices

研究概览

简要总结

The shortage of anesthetic agents can lead to intraoperative awareness while overdosing can trigger severe intra and postoperative problems. Therefore, monitoring anesthesia's depth (DoA: Depth of Anesthesia) is a crucial but still challenging task. Although some commercial monitors are based on electroencephalogram (EEG), designed to quantify DoA, their use in clinical practice has limitations. On the other hand, heart rate variability (HRV) has valuable information about physiological states, both from the heart and the organism. Classical indices derived from HRV have been shown to be able to differentiate the different stages of anesthesia. In this study, it is proposed to create a model to monitor DoA combining several HRV indices. Patients will be divided into three groups, according to the type of anesthesia to which they will be submitted (inhalation, total or balanced intravenous) and will have the electrocardiogram recorded during the entire surgical procedure. Various HRV indices will be calculated, and machine learning techniques will be used to combine and identify the most relevant index to compose a score that reliably represents DoA. Several commercial devices have been developed to monitor the level of consciousness during anesthesia. Among the most popular tools are included: Narcotrend TM (MonitorTechnik, Bad Bramstedt, Germany); the M-Entropy TM (GE Healthcare, Helsinki, Finland); Nindex SA (Controls, Montevideo, Uruguay) and the Bi-Spectral Index (BIS, TM Medtronic-Covidien, Dublin, Ireland). In this study, BIS or Nindex will also be monitored during the entire period that the patients remain anesthetized and will later be used to compose the DoA score based on HRV. As a result, a computer program will be created to monitor DoA in real-time.

详细描述

Anesthesia is a state of reversible unconsciousness induced by one or more pharmacological agents. The three main anesthesia components are analgesia (pain relief), amnesia (memory loss), and immobilization, including autonomic reflexes' inhibition for harmful stimuli.1 Drugs used to induce anesthesia, in general, have different effects on each of these three components mentioned above.

Anesthesia depth assessment ( DoA: from English, Depth of Anesthesia ) is essential for anesthetic practice. The DoA depends on two opposing factors: the amount of anesthetic agent administered to the patient and the stimuli produced during surgery, increasing the level of awareness, and the patient's nociception. The ideal level d the DoA involves the guaranteed unconsciousness and anti-nociception adequate during surgery without compromise the functions of vital organs. In other words, one of the main challenges for anesthetists is to identify the appropriate amount of anesthetic to be administered to avoid the unwanted effects of anesthetic shortages (leading, for example, to intraoperative awareness) or anesthetic overdose, which can cause severe problems during intra and postoperative periods. 2 Before using muscle relaxants, the appropriate level of DoA could be monitored by the absence of movements to painful stimuli; once, the surgical incision's lack of movements was a sure sign that the patient was not superficially anesthetized. However, with the muscle relaxants' adoption in the anesthetics protocols, other measures to ensure that anesthetic agents' concentrations were administered properly were necessary.

Becoming conscious during surgery is a major concern for patients and anesthesiologists. It is estimated that the incidence of consciousness during general anesthesia is low, around 0.04% to 0.3%. However, considering the high number of surgical interventions, accidental awareness during surgery represents thousands of cases worldwide. Therefore, despite being an old problem, awareness during anesthesia is still a very relevant issue in public health.

DoA inefficient may also lead to an imbalance nociception x anti-nociception intraoperatively, even without patient conscious pain. Nociceptive stimuli can substantially affect the physiological state, inducing, for example, tachycardia, hypertension, nausea, fainting, and, therefore, negatively influencing patients' postoperative period 1 Thus, careful and efficient monitoring of DoA is the key to minimizing both the possibility of accidental awareness in surgeries and the overdose of anesthetic agents. 3 However, despite the importance of monitoring d the DoA, it is not easy to quantify this parameter during general anesthesia, and several approaches have been proposed to accomplish this task.

Quantification of DoA:

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
0 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA patients (classification by the American Society of Anesthesiology) 1-3, of all ages, scheduled to undergo procedures under general anesthesia.

排除标准

  • Patients with craniofacial deformities in which it is not possible to place the EEG sensors.
  • Patients with severe eczema, allergy, or skin atopy.
  • Patients with a history of severe autonomic dysfunction.
  • Need of autonomic cardiac blockers during the intraoperative period.
  • Absence of Consent.

结局指标

主要结局

To create a new Depth of Anesthesia (DoA) Score based on Heart Rate Variability indices

时间窗: 12 months

Define a score capable of reflecting DoA, combining different indices derived from ECG, such as HRV.

次要结局

  • Time to wake up(12 months)
  • Incidence of intraoperative memory.(12 months)
  • Impact of the basal cognitive status on the HRV indexes (derived from ECG)(12 months)
  • Impact of the differnet anesthetic drugs on the HRV indices (derived from ECG)(12 months)
  • Impact of the anesthesia adjuvant drugs on the HRV indices (derived from ECG)(12 months)
  • Aldrete score(12 months)
  • Incidence of nausea and vomiting(12 months)
  • Time spent in PACU(12 months)
  • Incidence of delirium(12 months)
  • Impact of frailty on the HRV indexes (derived from ECG)(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Waynice N.P. Garcia

Assistant Professor, M.D, Ph.D

University of Sao Paulo

研究点 (1)

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