Emergence Delirium in Children: Total Intravenous Anesthesia With Propofol and Remifentanil Versus Inhalational Sevoflurane Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Occurrence of emergence delirium
研究概览
简要总结
Emergence delirium (ED) refers to a wide variety of behavioural disturbances that are commonly seen in children following emergence from anesthesia. ED can potentially be dangerous and have serious consequences for the child such as injury, increased pain, and dislodgement of medical devices, often requiring physical restraint or pharmacological control. Witnessing this behaviour can be stressful for parents, which can negatively affect their interaction with the healthcare system, and their relationship with the child, nursing staff and other healthcare providers. The investigators aim to minimize ED to reduce the distress experienced by patients and their parents. This study will compare the recovery profile of sevoflurane with that of propofol remifentanil and their associated incidence of ED. This study should enable us to determine which form of anesthesia is associated with the fewest incidences of ED in children.
详细描述
Purpose:
In children, both propofol-only anesthesia maintenance infusions and single postoperative propofol boluses have been shown to be efficacious at reducing ED when compared with sevoflurane only [13, 17]. Methodological problems in these studies include: the administration of sedative premedications, ED provocative study designs that do not reflect reasonable clinical practice with sevoflurane, and the use of inadequately validated ED outcome tools.
Based on our extensive institutional experience with TIVA, we believe that this technique is superior to sevoflurane with respect to the incidence of ED. However, this clinical impression has never been validated in an appropriately robust investigation, and sevoflurane remains the pediatric anesthetic of choice for most other North American pediatric anesthesiologists.
Hypotheses:
- The use of total intravenous anesthesia (TIVA), rather than sevoflurane (SEVO) will reduce incidence of ED, as measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale.
- The use of TIVA will not result in longer times to laryngeal mask airway removal and post anesthetic care unit (PACU) discharge when compared to SEVO.
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)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children having general anesthesia for elective strabismus or other suitable minor eye surgery
- •Age ≥ 2 and ≤ 6 years
- •Appropriate procedure and patient for LMA airway management
排除标准
- •Developmental delay or neurological injury
- •Psychotropic medications or psychiatric diagnosis
- •Abnormal lipid or carbohydrate metabolism
- •Deviations from the anesthesia protocol including an inability to secure pre-anesthetic intravenous access in the TIVA group
- •Severe anxiety in the pre-operative period requiring sedative. premedication according to the staff anesthesiologist's and family's assessment
- •Patients experiencing pain requiring analgesia, postoperative nausea or vomiting (PONV) during the study period
- •Patients seen in the pre-anesthetic assessment clinic, due to habituation to hospital environment
- •Growth chart percentiles of < 3% or > 97%
研究组 & 干预措施
1
干预措施: Propofol (Drug)
2
干预措施: sevoflurane (Drug)
结局指标
主要结局
Occurrence of emergence delirium
时间窗: 1 day
次要结局
未报告次要终点
研究者
Carolyne Montgomery
Principle Investigator
University of British Columbia