COMPARISON OF REVERSIBILITY OF SUGAMMADEX AND NEOSTIGMINE TO VECURONIUM USED AS MUSCLE RELAXANT UNDER GENERAL ANAESTHESIA
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- recovery from general anaesthesia after administration of reversal
研究概览
简要总结
Sugammadex is a modified γ-cyclodextrin designed to reverse the effects of the steroidal neuromuscular blocking agents (NMBAs) rocuronium and vecuronium by encapsulation with no effect on cholinergic transmission.In contrast to neostigmine, sugammadex rapidly and effectively re- verses moderate and deep levels of vecuronium-in- duced neuromuscular blockade (NMB) , and is also effective for immediate reversal of blockade. We wanted to compare between reversibility of sugammadex and neostigmine in prolonged surgeries . Aim is to compare the efficacy of sugammadex with neostigmine for reversal of the effects of vecuronium as muscle relaxant. Objective is to
compare the reversibility of neostigmine with sugammadex using TOF
To compare :
-
Time required for complete reversal .
-
Any residual paralysis / block with standard doses and requirement of added doses.
-
Side effect if any in post operative period (muscle pain , recurarization / apnea).
This study includes patients classified Under American Society of Anaesthesiologists Physical status I,II&III planned for surgery under general anesthesia.
Group A will receive neostigmine 0.05 mg/ kg . If TOF not till T4 then dose converted to 1 mg/ kg.
Group B will receive sugammadex 2mg/ kg. If in deeper plain of anaesthesia then 4 mg/ kg.
The onset, duration and side effects of post operative analgesia will be recorded and compared
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •age 18 to 65 years ASA grade 1 ASA grade 2 ASA grade 3 patient willing to participate in study prolonged duration surgery under general anaesthesia more than 4 hours.
排除标准
- •lack of valid informed consent ASA grade 4 patient with bleeding disorder patient on medication known to interact with neuromuscular blocking drugs.
结局指标
主要结局
recovery from general anaesthesia after administration of reversal
时间窗: Administration of reversal to 24 hours
次要结局
- time required for complete reversal using TOF
研究者
Payodhi Modi
Datta Meghe Institute of Higher Eduacation and Research
