EEG-guided Propofol Sedation Versus Standard Care for Oesophagogastroduodenoscopy and Colonoscopy in Children: A Randomised Controlled Trial to Improve Sedation Safety and Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time to wake up
研究概览
简要总结
The goal of this clinical trial is to compare electroencephalogram (EEG) guided propofol sedation versus standard care in paediatric patients aged 6-16 undergoing oesophagogastroduodenoscopy and colonoscopy. The main questions it aims to answer are whether EEG guided propofol sedation will result in:
- faster wake up time
- reduced time to discharge
- reduced cumulative propofol dosage
- lower incidence of intraoperative adverse events
- no difference in intraoperative undesirable movement
- lower incidence and severity of emergence delirium
- lower intraoperative depth of sedation Participants will wear an EEG sensor (Sedline) prior to undergoing propofol sedation until they wake up post procedure.
详细描述
BACKGROUND AND RATIONALE Oesophagogastroduodenoscopy (OGD) and colonoscopy in children are often performed under deep sedation with propofol. Titration of propofol dosage is based solely on cardiorespiratory parameters obtained from standard ASA monitoring. However, this method of propofol titration does not allow visualisation of the patients' brain response and often leads to under- or over-sedation. Under-sedation can lead to undesirable intra-operative movement and potential awareness, while over-sedation is associated with complications such as apnea, hypoxaemia, hypotension, prolonged time to awakening and delay in PACU discharge.(1,2)
Patients are often over-sedated during propofol anaesthesia. A study in adults undergoing colonoscopy using electroencephalography (EEG) monitoring showed that although providers planned for moderate-to-deep sedation, retrospective review of the EEG revealed that many patients were under general anesthesia, often with burst suppression (3) EEG burst suppression has been linked to postoperative deliriumin the elderly (4), and anesthesia titration to minimize burst suppression may decrease the incidence of postoperative delirium. Likewise, over-sedation and EEG isoelectric events are common in children undergoing propofol anesthesia with dosing based solely on population pharmacokinetics and patient haemodynamics. (5)
It was recently proposed that EEG monitoring and guidance during anaesthesia and sedation in children allows direct visualisation of each patient's brain response and complements current standard monitoring to enhance patient safety and experience.(2) EEG-guidance has been shown to reduce sevoflurane requirements in children undergoing general anaesthesia. (9) In particular, the EEG spectrogram, also called density spectral array (DSA), allows easy visualisation of the interactions between brain response, hemodynamic response, and changing procedural stimulation in real time, thus facilitating more precise and nuanced titration of anaesthetic agents. (2)
Processed EEG (pEEG) such as the bispectral index (BIS), Narcotrend index (NI) and patient state index (PSI) are dimensionless numbers derived from the EEG using manufacturers' algorithms to quantify anaesthetic depth (6). However, given the lack of clarity on how different pEEG numbers are computed and how they relate to fundamental neurophysiological properties of the developing brain, it is important to interpret the pEEG number in relation to the raw EEG waveform and spectrogram.
Only two small studies have compared EEG-guided propofol anaesthesia with standard care in children, both using the Narcotrend Index (NI). NI-guidance was shown to result in slightly faster recovery and lower drug consumption.(7)(8). To date, no study has utilised the spectrogram together with the pEEG number to guide anaesthesia. The investigators aim to compare EEG-guidance using Sedline EEG and spectrogram, in addition to the PSI, with standard care in children undergoing propofol TIVA for OGD and colonoscopy. Better visualisation of the brain response using the spectrogram may lead to more precise titration of propofol doses, lower propofol consumption and greater reduction in wake up time.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 16 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paediatric patients aged 6-16 who are undergoing oesophagogastroduodenoscopy and colonoscopy in KKH under propofol sedation
- •Parent/guardian must consent to participation in the study and patient must assent to participation in the study
排除标准
- •Patients with neurological diseases including seizure disorders
- •Patients with developmental delay or genetic syndromes
- •Patients with craniofacial deformities where it is not possible to place the EEG sensors
- •Patients with severe eczema or skin allergy or atopy
- •Patients who require sedative premedication or who require inhalational induction prior to initiation of propofol sedation
结局指标
主要结局
Time to wake up
时间窗: Through study completion, approximately 6 months
Our primary hypothesis is that in children aged 6-16, personalised EEG-guided anaesthesia care using the Sedline, (based on the raw EEG, density spectral array, in addition to the patient state index (PSI)), will result in faster wake up (defined as time from end of procedure to time of first eye opening) after propofol sedation for OGD and colonoscopy by 8 minutes
次要结局
- Time to discharge(Through study completion, approximately 6 months)
- Propofol dosage(Through study completion, approximately 6 months)
- Intraoperative adverse events(Through study completion, approximately 6 months)
- Depth of sedation(Through study completion, approximately 6 months)
- Emergence delirium(Through study completion, approximately 6 months)
- Undesirable movement(Through study completion, approximately 6 months)
