Peri- extubation dexmedetomidine infusion in mechanically ventilated young children - A Pilot randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- PGIMER
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. successful extubation ( defined as - Pateint free from invasive mechanical ventilation for 48 hours following extubation)
研究概览
简要总结
This is a pilot randomized controlled trial to evaluate the efficacy and feasibility of dexmedetomidine as a sedative agent in mechanically ventilated children between age of 1 month to 5 years in the peri- extubation period. Dexmedetomidine is a centrally acting alpha 2 agonist, commonly used in adult as well as pediatric ICU settings for it’s sedative, analgesic and anxiolytic properties. It is postulated to provide adequate sedation in mechanically ventilated children, while preserving natural respiratory drive. In this study, children who are mechanically ventilated for more than 48 hours and planned for extubation, will be enrolled and randomized to either intervention arm (Dexmedetomidine arm) or placebo arm via a computer-generated variable block randomization. Children in dexmedetomidine arm will receive dexmedetomidine infusion at 0.5mcg/kg/min (at 1ml/hour), while those in placebo arm will receive 0.9 percent saline at 1ml/hour. We will compare the rate of successful extubation as well as incidence of any drug related adverse effects, post extubation airway obstruction, peri- extubation agitation and sedation withdrawal as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •mechanically ventilated for more than 48 hours
- •planned for extubation in next 12 to 24 hours.
排除标准
- •Use of dexmedetomidine or clonidine within 12 hours prior to enrollment
- •Extubation for withdrawal of life support
- •Cardiovascular instability manifested by.
- •a. Mean arterial BP less than 5th centile for air despite adequate fluid and vasopressor resuscitation
- •Pateints having 2nd or 3rd degree heart block.
结局指标
主要结局
1. successful extubation ( defined as - Pateint free from invasive mechanical ventilation for 48 hours following extubation)
时间窗: 1. 48 hours following extubation | 2. in 24 hours following extubation
2.Post extubation airway obstruction
时间窗: 1. 48 hours following extubation | 2. in 24 hours following extubation
(defined as Wesley croup score more than/equal to 3 anytime in 24 hours following extubation
时间窗: 1. 48 hours following extubation | 2. in 24 hours following extubation
次要结局
- Recruitment rate ( defined as proportion of enrolled children(amongst total eligible children))
- Protocol adherence ( Time from randomization to initiation of trial drug infusion to extubation(Total duration of trial drug)
- Accidental extubation ( defined as Candidates who undergo self(extubation or accidental)
- Adverse drug effects( defined as Incidence of bradycardia (defined(as heart rate less than 70)/ hypotension)
- Peri- extubation agitation ( defined as RASS (Richmond agitation-(sedation scale) more than/equal to +1 ))
- sedation withdrawal ( defined as WAT score more than/equal to 3 )(48 hours post extubation)
研究者
Sushen Tandon
Post graduate institute of medical education and research