Monitoring the Depth of Anaesthesia in Children in the Course of a Surgical Procedure Using the BIS Monitor - Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Occurrence of perioperative complications
研究概览
简要总结
General anaesthesia (GA) is, according to many definitions, the greatest gift presented to the medical art (S. B. Nuland). One of the aims of GA is to achieve the optimal depth of anaesthesia and rapid emergence from general anaesthesia. In order to achieve this goal, it is necessary to observe the clinical condition of the patient, and at the same time monitor the patient's overall condition. With the currently available options of GA management (e.g. use of intravenous anaesthetics, strong analgesics and modern volatile anaesthetics, in combination with various methods of topical anaesthesia) the importance of methods measuring the depth of GA increases. The depth of GA may be defined as a continuous progressive decreasing of the central nervous system, together with a decreased reactivity to stimuli. In the course of GA, perioperative awareness is detected in 0.1-0.2% of cases. Awakening during a surgical procedure may result in significant psychological complications (e.g. post-traumatic stress disorder), and the patient may suffer from a serious long-time disorder.
详细描述
In order to prevent, or minimize the perioperative awareness, it is possible to utilize two different methods of depth of anaesthesia monitoring. The options may be divided into two basic groups: A/ The use of clinical monitoring and other methods (apart from CNS), and B/ Methods based on monitoring of the electrical activity of the brain. In the first group, it is possible to list the following options: 1. clinical assessment (Evans's score), 2. skin conductance, 3. isolated method of measurement at the forearm, 4. spontaneous superficial electromyogram (SEMG), 5. lower oesophageal contractility, and 6. various hearth rate. The possibilities of depth of GA monitoring using the scanning of electrical brain activity may be further subdivided into two groups: a/ methods based on EEG, and b/ methods assessing evoked potentials. In the group of methods based on EEG, the following devices may be used to monitor the depth of GA in practice:
a/ BIS monitor, b/ E-Entropy, c/ Narcotrend, and d/ SedLine Sedation Monitor. In the second group using evoked potentials it is possible to utilize monitors measuring electrical activity in certain areas of the brain, in relation to stimulation of specific sensory nerve pathways: a/ somatosensory, b/ visual, and c/ auditive evoked potentials.
Aims of the Study:
Null hypothesis: The use of depth of general anaesthesia monitoring in children in the course of a surgical procedure does not affect the number of post-operative complications related to the depth of GA, does not shorten the period of emergence from GA, does not decrease the amount of inhalation anaesthetics used, and does not decrease the amount of opioids used.
Primary aim: To test, whether the administration of anaesthesia in children in the course of a surgical procedure with the depth of general anaesthesia monitoring with the BIS monitor results in a decrease in the number of complications related to inappropriate depth of GA.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Days 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •appropriate age
- •informed consent form signed by both parents (according to national legislation)
- •need to undergo a procedure in general anaesthesia
- •ASA I classification
排除标准
- •non-signing of the informed consent form by both parents
- •ASA classification higher than I
研究组 & 干预措施
BIS Group
BIS monitor will be used during the GA monitoring, the BIS value will be known to the anaesthetist (investigator)
- GA induction (Phase 1):
- inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
- intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
- anaesthesia (Phase 2, Phase 3):
- hypnotic component: titration of Sevorane concentration, with the aim of achieving the BIS values of 40-60%, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
- analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
- relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
干预措施: BIS Group (Procedure)
BIS Group
BIS monitor will be used during the GA monitoring, the BIS value will be known to the anaesthetist (investigator)
- GA induction (Phase 1):
- inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
- intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
- anaesthesia (Phase 2, Phase 3):
- hypnotic component: titration of Sevorane concentration, with the aim of achieving the BIS values of 40-60%, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
- analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
- relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
干预措施: Anaesthetics (Drug)
Non-BIS Group
BIS monitor will be used during the GA monitoring, however the BIS value will not be known to the anaesthetist (investigator)
- GA induction (Phase 1):
- inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
- intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
- anaesthesia (Phase 2, Phase 3):
- hypnotic component: titration of Sevorane concentration, with the aim of achieving the MAC value appropriate for the age of the child, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
- analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
- relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
干预措施: Non-BIS Group (Procedure)
Non-BIS Group
BIS monitor will be used during the GA monitoring, however the BIS value will not be known to the anaesthetist (investigator)
- GA induction (Phase 1):
- inhalation introduction (Sevorane, 02,AIR (flow 2:2 l/min)) or
- intra-venous introduction: (Suphentanil: (0.1-0.3 ug/kg iv.), Propofol (2-2,5 mg/kg iv.), or Mivacron (0.15-2mg/kg ),Tracrium (0.3-0.6mg/kg)
- anaesthesia (Phase 2, Phase 3):
- hypnotic component: titration of Sevorane concentration, with the aim of achieving the MAC value appropriate for the age of the child, bearing gas mixture: O2/AIR (in proportion of 1:1, with 0.5:0.5 flows)
- analgesic component: Suphentanil (continuous dose of 0.1-0.3ug/kg iv. every 20-30 min)
- relaxation: Mivacron (continuous dose of 0.1mg/kg iv.), Tracrium(0.3-0.6 mg/kg) Patients in this group will be administered anaesthetic, in order to achieve and maintain the required general anaesthesia.
干预措施: Anaesthetics (Drug)
结局指标
主要结局
Occurrence of perioperative complications
时间窗: 24 months
The occurrence of perioperative complications due to inappropriate depth of general anaesthesia will be observed.
次要结局
- Decrease in the amount of analgesics used(24 months)
- Decrease in the amount of inhalation anaesthetic used(24 months)
- Shortening of the emergence from general anaesthesia(24 months)