Comparison of reversibility of Sugammadex between intermittent top-up and continuous infusion of Vecuronium in general anaesthesia.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reversibility from general anaesthesia when TOF 4 appears after administration of sugammadex in intermittent top-up and continuous infusion of vecuronium.
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**.** **Sugammadex rapidly and effectively re-verses moderate and deep levels of vecuronium-induced neuromuscular blockade (NMB) , and is also effective for immediate reversal of blockade. Lowest recommended dose is 2mg/kg. We wanted to compare its reversibility effect in vecuronium infusion and intermittent topup.**AIM :
To compare reversibility of sugammadex between intermittent top-up and continuous infusion of vecuronium in general anaesthesia .
OBJECTIVES
PRIMARY **OBJECTIVE :**To compare reversibility of sugammadex between intermittent top-up and continuous infusion of vecuronium in general anaesthesia .
SECONDARY OBJECTIVES : To compareTime required for complete reversal using TOF.
Any residual paralysis / block with sugammadex 2mg and requirement of added doses.
Side effect if any , in post operative period (muscle pain , apnea)
METHODOLOGY :
This study includes patients classified under American Society of Anaesthesiologists. Physical status I, II& III planned for surgery under general anesthesia will receive 2mg/kg Sugammadex
Group T will receive Intermittent top-up doses of Vecuronium.
Group CI will receive Continuous infusion of Vecuronium.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 years to 70 years ASA grade I/II/III Patient willing to participate in the study Surgery under general anaesthesia Duration 3 to 5 hours.
排除标准
- •Lack of valif informed written consent ASA grade IV Patients on medication known to interact with neuromuscular blocking drugs, eg.Antibiotics (aminoglycosides, tetracycline), antidepressants, anticonvulsants, antiarrhythmics (calcium channel blockers and quinidine) and magnesium sulphate and patients with known allergy to sugammadex.
结局指标
主要结局
Reversibility from general anaesthesia when TOF 4 appears after administration of sugammadex in intermittent top-up and continuous infusion of vecuronium.
时间窗: From time of administration of sugammadex to 30 min after administration
次要结局
- Time required for complete reversal using TOF.(Base line - time at which reversal drug was given.)
研究者
Dr SNEHAl KABRA
Datta Meghe Institute of Higher Education and Research