The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The diurnal phase shift
研究概览
简要总结
In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.
详细描述
Objective:
The primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery.
Secondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication.
Study procedures:
Possible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
The diurnal phase shift
时间窗: Baseline (1wk before anesthesia) - First night post-anesthesia
The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery.
次要结局
- Changes in all sleep times(3 days pre-anaesthesia - 7 days post-anaesthesia)
- Change in sleep quality(3 days pre-anaesthesia - 7 days post-anaesthesia)
- Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery(3 days pre-anaesthesia - 7 days post-anaesthesia)
- Difference in sleep-wake timing(3 days pre-anaesthesia - 7 days post-anaesthesia)
研究者
Jorinde Polderman
Pediatric Anesthesiologist, principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)