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临床试验/NCT04258007
NCT04258007已完成不适用

Recovery Profile of Sugammadex Versus Neostigmine in Pediatric Patients Undergoing Cardiac Catheterization: a Randomized Double-blind Study

Mansoura University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月27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
入组人数
50
试验地点
1
主要终点
Reversal efficacy

研究概览

简要总结

This study hypothesizes that Sugammadex may has more appropriate recovery profile than neostigmine in pediatric cardiac patients undergoing cardiac catheterization. In pediatric cardiac patients, clear and rapid recovery (fast-tracking) is required to maintain hemodynamic within the normal physiological values which may be saved by sugammadex

详细描述

There are numerous advantages of early tracheal extubation otherwise known as fast-tracking following anesthesia for congenital heart disease (CHD)

Early tracheal extubation not only eliminates the potential morbidity related to an endotracheal tube and mechanical ventilation such as atelectasis, accumulation of secretions, nosocomial infections, and the potential for airway trauma, it also limits the need for sedation and the antecedent adverse effects including respiratory and hemodynamic depression, tolerance, withdrawal, and delirium. Most importantly, the shift from positive pressure to spontaneous ventilation augments cardiovascular function and improves preload. Reversal of neuromuscular blockade is a fundamental aspect of emergence from general anesthesia. Historically, the only option to actively reverse blockade will be to administer anticholinesterase inhibitors, which are unable to reverse deep neuromuscular blockade. They are also associated with a variety of cholinergic side effects, including bradycardia, nausea, and increased secretions, which require concomitant administration of an anticholinergic agent, with its own adverse effects. Sugammadex is a newer, selective relaxant binding agent

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)

盲法说明

Double blind (Participant, Care Provider)

入排标准

年龄范围
1 Day 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists physical status (ASA) I-III

排除标准

  • Legal guardian refusal.
  • Any patients with known drug hypersensitivity.
  • Kidney failure.
  • Liver failure.
  • Diseases affecting the neuromuscular junction.
  • A history of malignant hyperthermia

研究组 & 干预措施

Reversal Neostigmine

Placebo Comparator

Patients undergoing cardiac catheterization will receive a combination of 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch

干预措施: Reversal Neostigmine (Drug)

Reversal Sugammadex

Active Comparator

Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch

干预措施: Reversal Sugammadex (Drug)

结局指标

主要结局

Reversal efficacy

时间窗: 90 minutes after endotracheal extubation

Mean time in minutes from start of sugammadex or neostigmine administration to recovery of T4/T1 ratio to 0.9 was assessed by applying repetitive train of four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. Nerve stimulation continued until the ratio of the magnitude of the fourth twitch (T4) to first twitch (T1) reached at least 0.9

次要结局

  • Heart rate(assessed basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal)
  • Mean arterial blood pressure(basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal)
  • Diastolic arterial blood pressure(basal, after induction, every 15 min during operation ,.just before reversal, and at 1,2,5,7,10,15 minutes after reversal)
  • vomiting(for 24 hour after sugammadex or neostigmine administration)
  • Peripheral oxygen saturation(basal, after induction, every 15 min during operation , just before reversal, at 1,2,5,7,10,15 minutes after reversal)
  • activated prothromboplastin time(intraoperative and for 60 minutes after sugammadex or neostigmine administration)
  • Anaphylaxis(for 24 hour after sugammadex or neostigmine administration)
  • blood glucose(preoperative, 15 minutes before reversal and 30 minutes after reversal)
  • prothrombin time(intraoperative and for 60 minutes after sugammadex or neostigmine administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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