Comparison of sedation efficacy of dexmedetomidine and midazolam in critically ill children - A single-blinded, parallel design, Randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Proportion of 2 hourly sedation data points in target range [ BIS target → 40 to 70 / RASS
研究概览
简要总结
Sedation in ICU using benzodiazepine agents is associated with increased delirium, withdrawal, length of stay translating into increased morbidity and mortality. Dexmedetomidine, on the other hand has shown to be atleast as efficacious as benzodiazepines while reducing the above-mentioned adverse effects. We propose to compare the sedation efficacies of the two drugs in terms of maintaining target sedation levels while also ensuring better patient morbidity outcomes. The study shall be a randomized, controlled, parallel group trial using midazolam and dexmedetomidine as sedative infusions for 5 days or till extubation whichever occurs is earlier. Level of sedation shall be monitored using Richmond agitation sedation scale (RASS) and Bi-Spectral Index monitor. All patients shall be under continuous cardio-respiratory monitoring. Basic demographic details, admission physiological scores - PRISM -3, pSOFA, vital parameters, basic investigations, dose of the sedative agents used, number of bolus doses required to maintain optimum sedation, length of ICU stay and ventilation duration shall be recorded. Withdrawal symptoms shall be monitored till day 28 of enrolment using Withdrawal Assessment Tool-1. Appropriate statistics shall be applied to analyze the collected data.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1.00 Month(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 month to 15 years admitted in PICU, on invasive mechanical ventilation with an endotracheal tube, expected to be requiring sedation and ventilation for more than 24 hours and having a RASS score of ≥ 1 at PICU admission.
排除标准
- •Primary central nervous system disease 2) Hepatic impairment 3) Patients on neuromuscular blocker agent intravenous infusions 4) Post cardiac surgery patients in the first 48 hours of surgery with high risk of low cardiac output state 5) Patients diagnosed with atrio-ventricular conduction blocks or past history of the same 6) Previous participation in the study 7) Consent denial.
结局指标
主要结局
Proportion of 2 hourly sedation data points in target range [ BIS target → 40 to 70 / RASS
时间窗: 5 days from enrolment or till extubation whichever is earlier
target → 0 to -4]
时间窗: 5 days from enrolment or till extubation whichever is earlier
次要结局
- Number of intermittent sedo-analgesic or neuromuscular agent bolus doses administered to maintain optimum sedation level(5 days of enrolment or till extubation, whichever occurs earlier)
- Incidence of Iatrogenic withdrawal syndrome(28 days of enrolment)
- Incidence of bradycardia and hypotension while on sedative infusion(5 days of enrolment or till extubation, whichever occurs earlier)
- Duration of mechanical ventilation(till extubation)
- Length of ICU stay(discharge from ICU)
研究者
Varun M Angadi
AIIMS Raipur