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临床试验/NCT05040490
NCT05040490Unknown不适用

Comparison of the Effects of Neostigmine and Sugammadex on Postoperative Residual Curarization and Postoperative Pulmonary Complications Detected by Diaphragm and Lung Ultrasonography: A Study Protocol for Prospective Double-blind Randomized Controlled Trial.

Peking Union Medical College Hospital0 个研究点目标入组 414 人开始时间: 2021年8月31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
入组人数
414
主要终点
incidence of postoperative pulmonary complications

研究概览

简要总结

This trial aims to compare the incidence of postoperative residual curarisation (PORC) and postoperative pulmonary complications (PPCs) in the SUG and NEO group by means of diaphragm ultrasonography and LUS, so as to conclude whether SUG can outperform NEO in preventing occurrence of PORC and PPCs.

详细描述

The incidence of postoperative residual curarisation (PORC) is about 2%-64% worldwide, which may be an underling risk factor of postoperative pulmonary complications (PPCs), causing many undesirable effects on patients. Thus, reversal drugs of neuromuscular blocking agents (NMBAs) such as neostigmine (NEO) and sugammadex (SUG) have been administrated, and SUG maybe perform better in preventing PORC. Different supplementary methods to help identify PORC or PPCs have also been reported, such as adductor of pollicis acceleromyography and lung ultrasound (LUS). Recently, diaphragm ultrasonography has been used to evaluate PORC, as a novel approach.In this prospective, double-blind, randomized controlled trial, we will enroll 414 patients of American Society of Anesthesiologists physical status I-III, aged over 60 years, who will be scheduled to undergo arthroplasty surgery under general anesthesia. Participants will be randomized into NEO and SUG group receiving neostigmine and sugammadex as reversal drug respectively. The primary outcomes will be the incidence of PPCs in NEO and SUG group respectively. The secondary outcome is the incidence of PORC in the two groups.We hypothesize that: 1) the incidence of PPCs is lower after reversal with SUG than with NEO, 2) using the method of diaphragm ultrasonography, the incidence PORC is lower after reversal with SUG than with NEO, 3) the incidence of PPCs can be predicted by LUS and by evaluating whether there is PORC through diaphragmatic ultrasound.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Aged over 60 years
  • Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
  • Scheduled to undertake joint surgery
  • Signed the informed consent form

排除标准

  • Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system
  • Those with diaphragm insufficiency or massive pleural effusion
  • Women who are pregnant or nursing
  • Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
  • Declined to participate

研究组 & 干预措施

SUG group

Experimental

sugammadex as reversal drugs

干预措施: sugammadex as reversal drugs (Drug)

结局指标

主要结局

incidence of postoperative pulmonary complications

时间窗: 30 days after surgery

incidence of postoperative pulmonary complications

次要结局

  • Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography(preoperatively, 10min and 30min after extubation for diaphragm ultrasonography and LUS)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie YI

deputy director of surgery department

Peking Union Medical College Hospital

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