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临床试验/EUCTR2018-002961-21-BE
EUCTR2018-002961-21-BE进行中(未招募)1 期

The effect of deep neuromuscular block and reversal with sugammadex on surgical conditions and perioperative morbidity in shoulder surgery using a deltopectoral approach

Z Leuven0 个研究点目标入组 52 人开始时间: 2018年9月21日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
52

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 18 years or older at enrollment
  • Subjects who are undergoing elective or semi-elective surgery to the gleno-humeral joint or the proximal humerus using a deltoideo-pectoral approach
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 43
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 9

排除标准

  • Inability to consent because of mental status
  • Open injuries involving the deltoid muscle
  • Previous open surgery on the shoulder joint
  • American Society of Anesthesiologists (ASA) physical status > II
  • Age < 18 or > 75 years old
  • Body mass index (BMI) <18,5 or > 35 kg/m²
  • Renal insufficiency: glomerular filtration rate < 40 ml/min
  • Impaired liver function: hepatic cirrhosis, cholestatic jaundice
  • Neuromuscular disease
  • Pregnant female subjects
  • Breastfeeding female subjects
  • Patients receiving medications known to interact with neuromuscular blocking agents
  • Allergy to any drug included in the anesthetic protocol

研究者

发起方
Z Leuven

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