2024-520075-28-01招募中2 期
The PREVENT AGITATION trial II – children ≤1 year
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
研究概览
简要总结
To evaluate the efficacy of clonidine for prevention of emergence agitation To describe the pharmacokinetic parameters of clonidine when administered as a single dose intraoperatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Pharmacokinetic, part A
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Paediatric patients (male and female), aged 3- ≤ 12 months
- •Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional
- •The legally acceptable representative for the study participant provides written informed consent/assent for the trial
排除标准
- •Cardiac disease incl. arrhythmia
- •Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
- •Mental retardation
- •Neurological disease including symptoms similar to emergence agitation
- •Has or is suspected of having a family or personal history of malignant hyperthermia
- •Has or is suspected of having an allergy to study treatment or its excipients
- •Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
- •Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)
- •Cardiac, neuro and trauma surgery
- •Ex-premature (<37 weeks)
- •Premedication with clonidine
- •Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
- •Critical illness incl. hemodynamic instability (inotropic drugs needed)
- •Bleeding requiring transfusion prior to scheduled anaesthesia
- •Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
- •Malignant disease
结局指标
主要结局
Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
Emergence agitation measured on the Watcha score (1= calm, 4= agitated and thrashing around)7. The incidence of emergence agitation (Watcha score >2 during stay in the postanaesthetic care unit).
Pharmacokinetic parameter estimates for compartmental Clearance (CL), Volume of distribution (V) and T½
Pharmacokinetic parameter estimates for compartmental Clearance (CL), Volume of distribution (V) and T½
次要结局
- The amount of additional opioid needed during stay in the postanaesthetic care unit (calculated as morphine equivalents) for treatment of postoperative pain
- No validated scale for assessment of PONV exists and PONV will be assessed by nausea/vomiting Yes or No. While vomiting is obvious, nausea may be considered to be present if the child refuses to eat and other causes are ruled out.
- The proportion of participants with 1) clinically relevant hypotension and, clinically relevant bradycardia, 2) clinically relevant bradycardia and clinically relevant apnoea.
研究者
Sponsor's representative Volker Classen
Scientific
Rigshospitalet
研究点 (1)
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