Incidence of Emergence Delirium in the PACU: Prospective Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,421
- 试验地点
- 1
- 主要终点
- The incidence of emergence delirium
研究概览
简要总结
Emergence delirium (ED) is serious complication in the postoperative period in paediatric anaesthesia, reported incidence is 20-60%. It is characterized by psychomotor and perception disorder with excitation of paediatric patients. Emergence delirium has impact on morbidity and even on mortality of paediatric patients in the postoperative period.
The potential risk factors for ED development include sevoflurane, which is the dominant anaesthetic agent used in the paediatric patients, and which is actually the only inhalation agent used for inhalation anaesthesia induction. The incidence of ED is higher in postoperative period, for example in the Post-anaesthesia Care Unit - PACU. Patients with ED are at higher risk of psychomotor anxiety, agitation, unintentional extraction of intravenous cannula, and nausea and vomiting. For the therapy of ED propofol, midazolam and eventually ketamine in a reduced dosage are used.
详细描述
After the approval of the study by the Ethics Committee of the University hospital Brno and registration of the protocol at clinicaltrials.gov, the incidence of emergence delirium (ED) using PAED, WATCHA and Richmond agitation and sedation scale (RASS) score in patients hospitalized in the post-anaesthesia care unit (PACU) after general anaesthesia, in the Departement of paediatric anaesthesia and intensive care unit, University Hospital Brno in the term from 1.9.2020 until 30.6.2021 will be measured.
Paediatric Emergence Delirium (PAED) score, WATCHA score and Richmond agitation and sedation scale (RASS) will be measured in 0., 5., 10., 15., and 20. minute after PACU admission and after obtaining RASS ≥ - 2 . Emergence delirium is defined as PAED score above 10 points. In the case of ED development, the duration of ED will be measured as well as the number of therapeutic interventions and the cumulative dose of administered sedatives. The average PAED, WATCHA, RASS scale will be reported, the incidence of postoperative nausea and vomiting (PONV) and the cumulative dose of administered antiemetics, the type of anaesthesia induction (inhalation vs. intravenous), type of anaesthesia (TIVA, combined, inhalational), length of the surgery, type of the surgery will be reported.
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 Month 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after general anaesthesia hospitalized in the PACU in the term rom 1.9.2020 until 30.6.2021.
排除标准
- •Patients in the age from 0 to 1 month.
结局指标
主要结局
The incidence of emergence delirium
时间窗: up to 60 minutes after PACU admission
The incidence of emergence delirium, defined as PAED score above 10 points and/or WATCHA score over 2 and or RASS over 1 minimally in one of the measurements. All measurements will be measured in 0., 5., 10., 15., and 20. minute after PACU admission. The first measurement (T0) will be intiated after first obtaining RASS over -2.
次要结局
- type of anaesthesia (TIVA, combined, inhalational)(up to 60 minutes after PACU admission)
- cumulative dose of administered sedatives(up to 60 minutes after PACU admission)
- The average PAED score(up to 60 minutes after PACU admission)
- The average RASS score(up to 60 minutes after PACU admission)
- The need for pharmacology intervention incidence(up to 60 minutes after PACU admission)
- type of the surgery(up to 60 minutes after PACU admission)
- The average WATCHA score(up to 60 minutes after PACU admission)
- type of anaesthesia induction (inhalation vs. intravenous)(up to 60 minutes after PACU admission)
- The duration of ED(up to 60 minutes after PACU admission)
- incidence of postoperative nausea and vomiting (PONV)(up to 60 minutes after PACU admission)
- length of the surgery(up to 60 minutes after PACU admission)
研究者
Petr Štourač, MD
Clinical Professor
Brno University Hospital