An Observational Study of Emergence and Hypoactive Delirium After Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Post-anesthesia negative behaviors (pain, emergence delirium and hypoactive delirium)
研究概览
简要总结
Early postoperative negative behaviour (ePONB), such as pain, emergence delirium (ED) and hypoactive delirium, is a relevant clinical problem during recovery from anesthesia. Specifically, many children often present with different forms of negative behavior namely ED, hypoactive delirium or pain. Such negative behavior differs in terms of evolution, treatment, prognosis and clinical implications. Furthermore, there is overlap between tools used to measurement postoperative pain and ED. As a result, the assessment of the different forms of negative behavior are often compromised by the presence of postoperative pain. Therefore, the application of scales used to measure negative behaviour in postanesthetic, non-surgical patients aged 3 years and under scheduled for elective MRI may clarify the presence of ED, hypoactive delirium and pain. An improved understating of postanesthetic negative behavior is important in order to help implement appropriate measures so as to better treat these patients.
详细描述
The restless recovery from anesthesia is a relevant clinical problem that can be present in up to 80% of surgical cases. The incidence varies with age, anesthetic agents, type of surgery, and definition of the children behavior.
Unsettle behavior after anesthesia is associated with patient injury, damage to incision sites, exacerbated parental anxiety, increased nursing workload and cost of the healthcare system. Moreover, agitated children are seven times more likely to have new-onset separation anxiety, apathy, eating and sleeping problems.
The term early postoperative negative behavior (e-PONB) includes different unsettle behaviors after awakening and differentiates early phase from later postoperative behavioral changes. The more relevant components of e-PONB have been identified as pain and Emergence Delirium (ED).
ED a mental disturbance during the recovery from general anesthesia consisting in hallucinations, delusions and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing in bed. ED occurs within the first 20 min of recovery from anesthesia and often lasts 5-15 minutes and is self-limited.
The five-item Pediatric Anesthesia Emergence Delirium (PAED) scale is the gold standard to assess ED in the pediatric population. However, the diagnosis of ED may be affected by the concurrent presence postsurgical pain. A recent investigation found that only three of the five items of the PAED are delirium-specific ('Eye contact, 'Awareness of the surroundings', 'Purposeful actions'), whereas the other two ('Restlessness' and 'Inconsolability') are noted. As a consequence, if the child has 'no eye contact' and is 'no aware of surroundings,' emergence delirium should be suspected. On the contrary, a child showing 'Abnormal facial expression,' 'Crying' and being 'Inconsolable,' likely suffers of pain. The ED I and II score have been defined as the sum of the first 3-item (eye contact, purposeful movement, and awareness of surrounding) and the last 2-item scores (restlessness and inconsolability) of the PAED scale, respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ≤ 3 years old, scheduled for elective MRI.
- •Patients whose parents are fluent in French or English.
排除标准
- •Intubated patients or have higher oxygen requirements
- •Parent/guardian refusal
- •As this study will be conducted with only one NIPE monitor, and it will be devoted to the patient for about 1 hours, two consecutive patients cannot be enrolled in the study. In this case, the second patient will be considered eligible but excluded, and data will not be collected.
结局指标
主要结局
Post-anesthesia negative behaviors (pain, emergence delirium and hypoactive delirium)
时间窗: 1 hour
Validation of NIPE as a tool to predict and assess post-anesthesia negative behaviors.
次要结局
未报告次要终点
研究者
Gianluca Bertolizio
MD, FRCPC, Associate Professor, Anesthesiologist
McGill University Health Centre/Research Institute of the McGill University Health Centre
