Comparison Between the Efficacy of Neostigmine Versus Sugammadex Reversal of Rocuronium Induced Neuromuscular Blockade In Paediatric Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
A reversal agent is commonly given to improve neuromuscular function after intra-operative administration of non-depolarizing neuromuscular blocking agents. The administration of conventional reversal agent neostigmine is associated with many undesirable side effects. For almost a decade, a new novel drug sugammadex has been used to specifically antagonize the effect of aminosteroidal neuromuscular blocking agents.
A total of 80 paediatric patients planned for general anaesthesia were divided into two groups and were given either neostigmine+atropine, or sugammadex for reversal once the operation had completed.
详细描述
RESEARCH HYPOTHESIS
- Sugammadex has a shorter recovery time (from TOF count of 2 or 3 to TOF ratio of more than 0.9) as compared to neostigmine.
- Sugammadex has a more stable haemodynamic profile as compared to neostigmine when used to reverse rocuronium induced neuromuscular blockade in paediatric patients.
- Sugammadex causes less complications or side effects when used in paediatric patients as a reversal for rocuronium induced neuromuscular blockade when compared to neostigmine.
This study was a prospective, double blinded, randomized control study involving 80 selected paediatric patients undergoing various surgeries under general anaesthesia in the operation theatre of Hospital University Sains Malaysia (USM), Kubang Kerian.
Sample size The sample size for this study was calculated using Power and Sample Size Calculation Programme Version 3.0.10.software based on different each respective objectives.
- To compare the recovery time from Train of four (TOF) count of 2 or 3 to TOF ratio of more than 0.9 between neostigmine and sugammadex in reversal of rocuronium induced neuromuscular blockade in paediatric patients.
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)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologist (ASA) physical status 1 and
- •Paediatric patients within the above criteria whom require rocuronium induced neuromuscular blockage for general anaesthesia
排除标准
- •Active or recent upper respiratory tract infection (within 2 weeks)
- •Haemodynamically unstable patients for example trauma, haemorrhage, sepsis, thyrotoxic or cardiac failure
- •Patients with pre-existing neuromuscular disorders
- •Patients with renal failure, with creatinine clearance of less than 30mmol/L
- •Patients requiring post-operative ventilation
- •Patients with known allergy to sugammadex or neostigmine
研究组 & 干预措施
Neostigmine
1 mg of Atropine (1ml) was mixed with 2.5mg of Neostigmine (1ml) and diluted into 10mls with Normal Saline 0.9% in a 10ml standard syringe.
干预措施: Neostigmine (Drug)
Sugammadex sodium
100mg Sugammadex (1ml) is diluted into 10mls in a standard 10mls syringe with Normal Saline 0.9%.
干预措施: Sugammadex Sodium (Drug)
结局指标
主要结局
Recovery time
时间窗: From the time the reversal drugs (neostigmine or sugammadex) were given at TOF count of 2-3 till the TOF ratio is more than 0.9 up to 5 minutes after the operation finished
To assess the recovery time from TOF count of 2 or 3 to TOF ratio of more than 0.9 between neostigmine or sugammadex in reversal of rocuronium induced neuromuscular blockade in paediatric patients.
次要结局
- Oxygen saturation(From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.)
- Blood Pressure(From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.)
- Adequate ventilation(From the time of the reversal drugs (neostigmine or sugammadex) were given till patient achieved good ventilation (tidal volume 6 ml/kg) up to 5 minutes after the operation finished)
- Extubation time(From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is extubated up to 5 minutes after the operation finished.)
- Heart Rate(From the time of the reversal drugs (neostigmine or sugammadex) were given till the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.)
- Number of patients with treatment related-adverse event as assessed by clinical observation(From the time of the patient extubated until the patient is discharged throughout the time the patient stays at the recovery bay up to 30 minutes.)
研究者
Rhendra Hardy Mohamad Zaini
Doctor
Universiti Sains Malaysia