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临床试验/CTRI/2025/08/093785
CTRI/2025/08/093785尚未招募2 期

Efficacy of Sugammadex in reversal of Rocuronium versus Vecuronium induced Neuromuscular Blockade - a randomized controlled double blind trial

Gunnam Lakshmi Prathyusha1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年9月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To assess the time (in minutes) needed to achieve a TOF ratio of greater than 0.9 after administration of sugammadex.

研究概览

简要总结

This randomized study aims to evaluate the efficacy of sugammadex in reversing neuromuscular block induced by rocuronium versus vecuronium in adult patients undergoing elective surgery under general anesthesia. Neuromuscular blockade is routinely achieved using steroidal agents such as rocuronium and vecuronium, and reversal is traditionally done with neostigmine, which carries risks of incomplete recovery and adverse effects. Sugammadex, a novel  gamma cyclodextrin, offers rapid and predictable reversal by encapsulating these agents, with a higher binding affinity for rocuronium. Patients will be randomized into two groups Group R which is rocuronium with sugammadex and Group V which is  vecuronium with sugammadex. The primary outcome is time to recovery of train-of-four ratio greater than 0.9. Secondary outcomes include hemodynamic stability and adverse effects. The results may guide anesthesiologists in optimizing the choice of neuromuscular blocking agent when sugammadex is planned for reversal.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients posted for Elective Surgery under General Anaesthesia.
  • American Society of Anaesthesiologists (ASA) physical status I and II.

排除标准

  • Neuromuscular disorder.
  • Suspected renal insufficiency.
  • Significant hepatic dysfunction.
  • Allergy to one of the drugs used in this study.
  • Pregnant and breast-feeding.
  • Surgery more than 2 hours.

结局指标

主要结局

To assess the time (in minutes) needed to achieve a TOF ratio of greater than 0.9 after administration of sugammadex.

时间窗: To assess the time (in minutes) needed to achieve a TOF ratio of greater than 0.9 after administration of sugammadex.

次要结局

  • To assess Hemodynamic Parameters (SBP, DBP, MAP, HR, SP02) at 2, 5, 10, 15, 30, 60, 120 minutes.

研究者

发起方
Gunnam Lakshmi Prathyusha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gunnam Lakshmi Prathyusha

Kalinga Institute Of Medical Sciences

研究点 (1)

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