The Influence of Electroencephalographic Density Spectral Array Guidance of Sevoflurane Administration on Recovery From General Anaesthesia in Children Between 6 Months and 12 Years.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- The Influence of DSA Monitoring on the Speed of Emergence.
研究概览
简要总结
In this randomised, blinded study, we will investigate the influence of DSA on recovery from general anaesthesia. DSA monitoring provides continuous information on depth of hypnosis. Based on DSA monitoring dose adjustments of sevoflurane can be made. We expect that this will lead to a faster speed of emergence and recovery.
详细描述
Electroencephalographic density spectral array (DSA) is a three dimensional method to display electroencephalogram (EEG) signals consisting of the EEG frequency (y-axis), the power of the EEG signal (colour-coded to be integrated into a two dimensional plot) and the development of the EEG power spectrum over time (x-axis). DSA is routinely used to measure depth of hypnosis (DoH) by a part of the staff members in our department. When DSA is used, dose adjustments of sevoflurane will be made based on monitoring depth of anaesthesia. However, most of our colleague do not use DSA. Dose adjustment is then based on (subjective) clinical surrogate parameters, or in general mostly based on a minimal alveolar concentration of the anaesthetic gas that is used.
Electroencephalographic DSA monitoring provides continuous objective information on DoH and should result in a faster speed of emergence and recovery from general anaesthesia (GA). This will be addressed in a randomised controlled trial.
In patients randomised to the intervention group, the anaesthetic agent sevoflurane will be administered on the basis of objective measures of anaesthetic depth, the typical DSA pattern for GA. We expect a significantly faster speed of emergence and recovery in the intervention group based on clinical experience. The Narcotrend monitor is validated for use in paediatric patients. There are thus no additional risk factors apart from those, which are inherent with general anaesthesia. Patient randomised to the control group will receive standard treatment, that is delivery of sevoflurane based on a MAC of 0.9 respectively an end tidal sevoflurane concentration of 2.3%. A non-invasive therapeutical intervention (DSA based conduct of GA) should result in the advantage of faster recovery, without any additional risk factor.
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, Outcomes Assessor)
盲法说明
The patient and parents will be blinded to the treatment. The outcome assessor will be blinded as well.
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent of parents/guardians
- •Age ≥6 months and ≤12 years
- •Surgical procedure requiring GA supplemented with caudal analgesia
- •Ability of the parents/guardians to communicate in Dutch
排除标准
- •Primary exclusion criteria
- •Withdrawal of informed consent
- •(Chronic) use of drugs influencing the electroencephalogram
- •Use of premedication
- •Known intolerance for sevoflurane
- •Parents/guardians unable to communicate in Dutch
- •Secondary exclusion criteria
- •Protocol violation
- •Data registration failure
研究组 & 干预措施
Control
In patients randomised to the control group, sevoflurane will be titrated according to a Minimal Alveolar Concentration (MAC) of 0.9 respectively an end tidal sevoflurane concentration of 2.3% based on standard practice in our paediatric anaesthesia department.
Treatment
In patients randomised to the intervention group of the trial, the anaesthetic agent sevoflurane will be titrated according to the typical DSA pattern for general anaesthesia with sevoflurane, provided by the Narcotrend
干预措施: Narcotrend Monitor (MT MonitorTechnik, Hannover, Germany) (Device)
结局指标
主要结局
The Influence of DSA Monitoring on the Speed of Emergence.
时间窗: Day 0
The speed of emergence is defined as the time interval between the end of hypnotic drug application and the moment when discharge criteria from the operating room are met (defined as a Steward score ≥ 3) The Steward recovery score consists of three domains: consciousness, airway and motor. Consciousness can be scored from 0-2, in which 0 equals non responsive, 1 equals response to stimuli, 2 equals awake. Airway is scored from 0-2: airway that requires maintenance scores 0, maintaining good airway scores 1 and coughing on command or crying scores 2. Motor is also scored form 0-2: no movement scores 0, non-purposeful movement scores 1 and purposeful movement scores 2. Combining all three domains, the minimum score is 0 (unconscious) and the maximum score is 6 (completely awake) The speed of emergence is defined as a minimum score of 3, with a minimum score of 1 in each domain.
次要结局
- Total Time From Discontinuation of Anaesthetic Drug Delivery Until Discharge From the Post Anaesthesia Care Unit.(Day 0)
- Differences of Depth of Hypnosis During the Procedure, as Measured by the Narcotrend Monitor.(Day 0)
- The Incidence of Postoperative Delirium(Day 0)
- Incidence of Recall of Events During the Procedure (Awareness)(Day 0, Day 1, Day 14)
- The End-tidal Sevoflurane Concentration(Day 0)
研究者
Hannah Raab
BSc
Erasmus Medical Center