Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- The incidence of emergency delirium
研究概览
简要总结
Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None (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
- 否
入选标准
- •Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
- •Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
- •A parent signed the informed consent form.
排除标准
- •Suffering important organ diseases;
- •History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
- •History of severe hearing or visual impairment;
- •Children are not suitable for inhalation anaesthesia considered by the researchers;
- •The parent involving in this trial spends less than three months a year with the child;
- •The parent is not competent for companionship considered by the researchers;
- •Neither father nor mother is able to participate in the screening interview and the trial.
结局指标
主要结局
The incidence of emergency delirium
时间窗: At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED). When the child wakes up in the PACU (the child can stay awake for more than 10 seconds), and 5min, 15min, 25min after waking up, a trained researcher will evaluate the PAED score (the maximum scores ≥10 will be diagnosed as ED).
次要结局
- The severity of emergency delirium(At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;)
- The incidence of postoperative maladaptive behaviours(at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery)
- Sleep quality(Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery)
- Compliance of anaesthesia induction(The period anaesthesia induction.)
- Postoperative pain score(At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.)
- Preoperative anxiety of children(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)
- Preoperative anxiety of parents(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)
- The severity of emergency delirium(At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;)
- The incidence of postoperative maladaptive behaviours(at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery)
- Sleep quality(Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery)
- Quality of life score(Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.)
- Compliance of anaesthesia induction(The period anaesthesia induction.)
- Postoperative pain score(At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.)
- Preoperative anxiety of children(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)
- Preoperative anxiety of parents(Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.)
研究者
TING LI
Principal Investigator
Second Affiliated Hospital of Wenzhou Medical University