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临床试验/CTRI/2025/06/088927
CTRI/2025/06/088927已完成2/3 期

A Prospective Randomized Study to Compare the Post operative side effects of sugammadex vs neostigmine for reversal of vecuronium-induced neuromuscular blockade in patients undergoing CORONARY ARTERY BYPASS GRAFTING off pump

Kiranmuthrajah1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年6月28日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
112
试验地点
1
主要终点
Time from reversal administration at least 3 TOFR equal to or more than 0.9

研究概览

简要总结

This prospective, randomized clinical study was designed to compare the postoperative side effects of sugammadex versus neostigmine in reversing vecuronium - induced neuromuscular blockade in patients undergoing off-pump coronary artery bypass grafting (CABG). Eligible patients were randomly allocated to receive either sugammadex or neostigmine at the end of surgery. The objectives of the study was time to onset of train of four from time of administration of reversal agents and evaluations of postoperative complications such as bradycardia, hypotension, nausea, vomiting, residual neuromuscular blockade, need for NIV support, need for reintubation ,cardiac arrest. The aim of the study was to determine safer and more effective reversal agent in context of CABG-off pump surgeries, where rapid and smooth recovery from neuromuscular blockade is critical.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 18 years of age or older
  • Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy.

排除标准

  • Age less than 18 years
  • Patient scheduled for emergency or redo surgeries
  • Patients with history of COPD / Pulmonary hypertension / hepatic or renal dysfunction.

结局指标

主要结局

Time from reversal administration at least 3 TOFR equal to or more than 0.9

时间窗: 3 minutes / 5 minutes / 10 minutes / 20 minutes / 30 minutes / 1 hour / 2 hour

次要结局

  • Time of extubation from discontinuation of inhaled anaesthetic,(Need for reintubation,)

研究者

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

Dr Kiran Muthu Rajah

Sri Ramachandra Institute of Higher Education and Research

研究点 (1)

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