Effectiveness of Sugammadex on Muscle Relaxant Reversal in Preterm Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessment of reversal
研究概览
简要总结
The primary aim of the work is to compare the efficacy of Sugammadex and neostigmine in reversing rocuronium-induced muscle relaxation to reach complete recovery of neuromuscular block (TOF ratio≥ 0.9) in preterm neonates.
The secondary aim is to evaluate the safety of using Sugammadex in preterm neonates and to detect any complications that may occur in this age group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
via the closed envelope method
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm neonates
- •scheduled for elective inguinal hernia repair
排除标准
- •drug hypersensitivity
- •patient is with any diseases affecting the neuromuscular junction
- •Patients with family history of malignant hyperthermia
研究组 & 干预措施
(Group N)
patients in this group will receive 0.02 mg/kg atropine with neostigmine 0.05 mg/kg IV. to reverse the action of the neuromuscular blocker given.
干预措施: Neostigmine (Drug)
(Group S)
the patients will receive Sugammadex 2mg/kg IV. As the reversal agent
干预措施: Sugammadex (Drug)
结局指标
主要结局
Assessment of reversal
时间窗: immediately after the surgery
Reversal time which is defined as time in seconds from the start of administration of sugammadex or neostigmine to recovery of TOF ratio to 0.9
Evaluation of recovery
时间窗: immediately after the surgery
Time for modified Aldrete score to reach 10
次要结局
- number of patients with Complications(immediately after the surgery)
研究者
Yasser Mohamed Mohamed Osman
assistant professor of anesthesia Alexandria university
Alexandria University