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临床试验/NCT03619759
NCT03619759已完成不适用

The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 585 人开始时间: 2018年3月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
585
试验地点
1
主要终点
Length of stay

研究概览

简要总结

This study is retrospective study. The purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.

详细描述

Abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block during surgery. After the surgery, reversal agent of neuromuscular blocking agent is given almost every pateints who underwent general anesthesia.

Classic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. Its action mechanism is competetive antagonist of rocuronium. But cholinesterase inhibitor cannot make complete reversal in moderate or deep neuromuscular block. Its incomplete reversal which is called residual block cause respiratory complications and prolongation hospital stay.

Sugammadex has different mechanism compared to cholinesterase inhibitor. It captures neuromuscular agent, especially rocuronium, and prevent rocuronium's action. Even in deep neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect is fater and more reliable compared to cholinesterase inhibitor.

Previous studies focused on only short term outcome of sugammadex, like postanesthetic care unit (PACU) discharge time, respiratory complications in PACU.

But in this study, longer term outcome will be comapred between sugammadex group and cholinesterase inhibitor group (pyridostigmine).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 21~80
  • Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017
  • Exclusion criteria
  • Emergency surgery
  • Paraplegia or quadriplegia
  • Bedridden state d/t various reason
  • Neuromuscular disease
  • Combined operation wth other surgery

排除标准

  • 未提供

研究组 & 干预措施

Sugammadex

Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation

干预措施: Sugammadex (Drug)

结局指标

主要结局

Length of stay

时间窗: admission to discharge (within 1 month)

Length of stay in hospital

次要结局

  • Readmission rate(30 days after discharge)
  • Time to first successful oral intake(within 30 days)
  • postoperative complication rate(after colorectal surgery, within 30 days)

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

In-kyong Yi

Clinical assistant professor

Ajou University School of Medicine

研究点 (1)

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