The PREVENT AGITATION Trial II - Children ≤1 Year
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 336
- 试验地点
- 3
- 主要终点
- Compartmental clearance for pharmacokinetic profiling.
研究概览
简要总结
Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
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, 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
- •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)
研究组 & 干预措施
Clonidine
Participants receive Clonidine solution for injection, 3 microg/kg, administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Injection is administered from a dilated solution of Clonidine 15 microg/mL (ie., 0.2 mL/kg).
干预措施: Clonidine (Drug)
Placebo
Participants receive Sodium Chloride isotonic (9mg/mL) solution for injection administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Dosage is administered according to weight: 0.2 mL/kg.
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Compartmental clearance for pharmacokinetic profiling.
时间窗: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
Volume of distribution for pharmacokinetic profiling.
时间窗: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
Incidence of emergence agitation during stay in postanaesthetic care unit (PACU)
时间窗: From admission to PACU to discharge from PACU, up to app. 4 hours. Emergence agitation is considered present ("Yes"), if Watcha score>2 at ANY time point within the given time frame.
Participants will be assessed on Watcha scale (1=calm, 4=agitated and thrashing around) every 15 minutes from arrival to PACU till discharge therefrom. Emergence agitation is defined dichotomously as Yes/No, Yes being if any Watcha score \>2.
T1/2 for pharmacokinetic profiling.
时间窗: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.
Pharmacokinetic sampling will be performed in 1 mL EDTA tubes and analysed for clonidine plasma concentration in migrog/L
次要结局
- Proportion of participants with Postoperative Nausea and Vomiting (PONV)(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Mean sedation level in PACU(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Proportion of participants with postoperative pain(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Safety and tolerability of clonidine in infants 3-12 months of age: proportion of participants with adverse events of clinical interest(From administration of intervention through end of anaesthesia and PACU stay (up to app. 4 hours). Supplemental Adverse Event follow-up at 24 hours, 48 hours in case of ongoing adverse events and at 30 days post-intervention.)
- Mean amount of additional opioid administered in PACU(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Mean time to discharge readiness(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Mean time to postoperative feeding/oral intake(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Mean time to administration of opioid i PACU(From admission to PACU to discharge from PACU, up to app. 4 hours.)
- Mean time to awakening(From admission to PACU to discharge from PACU, up to app. 4 hours.)
研究者
Arash Afshari
MD, PhD
Rigshospitalet, Denmark