Open Clinical Trial to Evaluate Safety, Tolerability, and Efficacy of Dexdor for Sedation in Paediatric Patients in Intensive Care Settings. Multi-centre Trial in Russia for Marketing Registration of Dexdor.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients
研究概览
简要总结
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
详细描述
Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric experiences in the literature are in the form of small studies and case reports.
Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical situations. Based on literature analysis, dexmedetomidine may be potentially used in the intensive care unit in pediatric patients who require sedation, either breath spontaneously or require mechanical ventilation.
Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to further evaluate its safety and efficacy in all age ranges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 12 to 17 years;
- •Clinical need for prolonged (>24h) light to moderate sedation in patients with spontaneous or artificial ventilation
- •Negative urine pregnancy test (for female patients);
- •Written informed consent
排除标准
- •Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury; any other disorder where sedation assessment is not reliable due to any neurological conditions;
- •Uncompensated acute circulatory failure;
- •Severe hypotension or hypertension
- •Severe bradycardia or tachycardia
- •A/V-conduction block II-III;
- •Severe hepatic impairment
- •Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data;
- •Use of centrally acting alfa-2 agonists or antagonists in the period less than 5x halflife between drug discontinuation and the time of randomisation;
- •Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- •Patients receiving sedatives for therapeutic indications (e.g. epilepsy);
- •Patients allergic to dexmedetomidine and rescue medications
- •Hemodialysis and peritoneal dialysis;
- •Those requiring deep sedation or neuromuscular blocking agents;
- •Burn injuries and other injuries requiring regular anaesthesia or surgery;
- •History / family history of malignant hyperthermia;
- •Patients unlikely to be weaned from the ventilator during the study;
- •Patients with early-onset ventilator-associated pneumonia;
- •Any investigational drug within the preceding 30 days;
- •Any other reason which in the investigator's opinion would make it detrimental for the subject to participate in the study.
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine 100microg/ml
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Evaluation of efficacy of Dexdor for prolonged sedation in pediatric patients
时间窗: max 5 days
Time spent in target sedation range (RASS score )
Evaluation of Dexdor efficacy for prolonged sedation in pediatric patients
时间窗: max 5 days
Proportion of patients requiring rescue medication used for inadequate sedation (rescue-medication)
次要结局
- Time to extubation.(max 5 days)
- Time to first rescue medication(max 5 days)
- Wake-up/discontinuation of sedation (if applicable)(max 5 days)