Efficacy aNd safety of Sugammadex on duration of mecHanical ventilAtion in patients who received Neuromuscular blockade in the ICU – A multicEntre randomized controlled trial (ENHANCE)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- ICMR
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Primary- To assess the effect of duration of mechanical ventilation in sugammadex compared to control group.
研究概览
简要总结
Neuromuscular blocking agents (NMBs) are routinely used in perioperative settings and in critically ill patients. These drugs facilitate intubation. NMBs are also used as a prolonged infusion in ventilator patient asynchrony, raised intracranial pressure, proning and severe acute respiratory distress syndrome. Neostigmine is the reversal agent routinely used in perioperative settings, but not used in an ICU setting, as the patient is allowed to naturally come out of the NMB action. Sugammadex is another reversal agent released in the year 2022. It is a gamma cyclodextrin that forms the complex with vecuronium or rocuronium and reduces the neuromuscular blocking agent available for binding to nicotinic receptors. Its advantages are rapid reversal and fewer adverse effects. The efficacy and safety is however not well studied in the ICU settings. Hence we propose a trial in the ICU to evaluate its effect on duration of ventilation and ICU stay.
The primary outcome of the study is duration of mechanical ventilation. Primary- To assess the effect of duration of mechanical ventilation in sugammdex compared to control group. Secondary-1) To compare the length of ICU stay in sugammadex and control group 2) To compare the incidence of ICU acquired weakness in sugammadex and control group. Tertiary – To study the Cost effectiveness analysis using incremental cost effectiveness ratio (ICER).
This is a randomised parallel group placebo controlled b study. Study group will receive sugammadex and placebo group will receive 0.9% saline
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients on invasive mechanical ventilation Received neuromuscular blocker infusion (rocuronium or vecuronium) at least for 6hrs, or received two or more doses of NMBA, excluding the dose received during intubation
- •The decision of stopping of NMBA infusion/bolus has been taken by the clinical team and there is no longer requirement of NMB as per the evaluation.
- •Patients with renal failure with creatinine clearance more than 30 ml/min.
- •4.Patients with renal failure with creatinine clearance of less than 30 ml/ min and already initiated on renal replacement therapy.
排除标准
- •1.Pregnancy 2.Lactation 3.any known allergy to sugammadex.
- •4.Patients with decision of limitation of care based on shared decision making process.
- •5.Patients with neuromuscular weakness (diagnosed critical illness neuromyopathy) or any other preexisting neurological or neuromuscular illness that can interfere with assessment.
- •Patients transferred from another healthcare facility with neuromuscular weakness or without reliable details of previous medications.
- •7.Patients who have received invasive mechanical ventilation in the current admission and extubated and readmitted to ICU.
结局指标
主要结局
Primary- To assess the effect of duration of mechanical ventilation in sugammadex compared to control group.
时间窗: Outcome will be assessed upto 1 week after the administration of sugammadex.
次要结局
- To compare the incidence of ICU acquired weakness in sugammadex and control group
- To compare the length of ICU stay in sugammadex and control group.
- Tertiary – To study the Cost effectiveness analysis using incremental cost effectiveness ratio (ICER).(Till the ICU discharge)
研究者
Dr Amarja Havaldar
St Johns medical college