Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Residual curarization rate
研究概览
简要总结
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
详细描述
Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.
In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •elective general anesthesia
- •Female gender
- •Between the ages of 18-65
排除标准
- •Pregnancy
- •Contraindication to use of anesthetic drugs
- •Kidney failure
- •Liver failure
- •Heart failure
- •BMI <18 and BMI > 35 kg/m2
- •anticipated difficult airway
- •neuromuscular disease
- •Use of drugs that impair neuromuscular transmission
- •Patients who develop unexpected massive hemorrhage
- •Those who do not have the ability to read, understand and sign the consent form
- •Refusal of patient
结局指标
主要结局
Residual curarization rate
时间窗: through study completion an average of 3 months
Pecents of Patients TOFR\<0.9
HR
时间窗: through study completion an average of 3 months
Heart Rate
SPO2
时间窗: through study completion an average of 3 months
peripheric oxygen saturation
MAP
时间窗: through study completion an average of 3 months
Mean arterial pressure
次要结局
- PONV(through study completion an average of 3 months)
- Time to Return of bowel movements(through study completion an average of 3 months)
研究者
aysun postaci
Principal Investigator
Ankara City Hospital Bilkent