Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
研究概览
简要总结
The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •<37 gw at birth
- •<72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or >72 hours postnatal age, primary or reintubation
- •Informed consent from parents
排除标准
- •Intubation directly postnatally at the delivery room
- •Asphyxia (apgar <4 at 10 min, Umb-pH <7,0
- •S-Potassium > 6,5
- •Major malformations
- •Postsurgery intubation
- •Included in an other intervention study first week in life
- •Other intervention study
结局指标
主要结局
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
时间窗: 6-9 months
次要结局
- Pain score at intubation(6-9 months)
- Biochemical stress/pain response(6-9 months)
- Physiological stress/pain response(6-9 months)
- Behavioural stress/pain response(6-9 months)
- Neurophysiological stress/pain response (aEEG)(6-9 months)