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临床试验/CTRI/2024/12/078115
CTRI/2024/12/078115尚未招募不适用

Sugammadex Vs Neostigmine As A Reversal Agent In Patient Undergoing Thoracic Surgery Prospective randomized Observational Study

D Y Patil School Of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To assess the effective reversal of neuromuscular blockade in thoracic surgery using sugammadex in comparison to neostigmine

研究概览

简要总结

Neuromuscular blocking drugs are considered essential because they can facilitate airway instrumentation and improve surgical conditions. Residual neuromuscular block is associated with upper airway obstruction,hypoxaemia,atelectasis and pneumonia.Furthermore, even low levels of neuromuscular block (train-of-four [TOF] ratio <0.9 or <0.95) in healthy volunteers not exposed to anaesthesia or surgery was associated with pharyngeal and laryngeal dysfunction, and depressed hypoxic ventilatory drive.

Sugammadex is a modified gamma cyclodextrin, a selective binding agent that antagonizes neuromuscular blockade produced by amino steroid non-depolarizing muscle relaxants like rocuronium and vecuronium.

Compared to acetylcholinesterase inhibitors like neostigmine , sugammadex  is associated with a faster reversal of neuromuscular blockade. Patients undergoing thoracic surgeries require a deeper level of neuromuscular blockade to prevent diaphragmatic movement from interfering with the procedure and hence are at high risk of incomplete neuromuscular recovery and associated complications.Patient will be taken into OT , monitors attached , vital parameters like heart rate , SPO2 , Mean arterial pressure  and  blood pressure will be  monitored. Hemodynamic changes at the time of reversal  and time taken for emergence from anaesthesia and effectiveness of reversal post administration of Sugammadex ( 1.8 – 4.4mg/kg) will be assessed.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Elective thoracic surgeries Patients between 18years to 60years Patients giving consent for study.

排除标准

  • Patients with severe hepatic, renal, endocrine and cardiac dysfunction Pregnant and lactating patients Patient not willing to participate in study.

结局指标

主要结局

To assess the effective reversal of neuromuscular blockade in thoracic surgery using sugammadex in comparison to neostigmine

时间窗: At start of reversal , 2 mins , 4 mins , 6 mins , 8 mins, 10 mins , 1 hour , 6 hours post extubation

次要结局

  • To assess haemodynamic changes and residual muscle weakness(At start of reversal , 2 mins , 4 mins , 6 mins , 8 mins, 10 mins , 1 hour , 6 hours post extubation)

研究者

发起方
D Y Patil School Of Medicine
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vinod Rajan

D Y Patil School Of Medicine

研究点 (1)

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