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临床试验/EUCTR2012-001886-33-GB
EUCTR2012-001886-33-GB进行中(未招募)1 期

Randomized, Controlled, Parallel-Group, Double-Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-00 also known as SCH 900616, PO7982) - Effects of Depth of NMB & Insufflation Pressure on Surgical Conditions

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 127 人开始时间: 2012年11月22日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
127

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

入选标准

  • Subjects must be: Males/Females = 18 yrs; ASA (American Society of Anesthesiologists) Class 1, 2 or 3; scheduled for laparoscopic cholecystectomy (standard 4-hole) procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil and is expected to undergo rocuronium-induced neuromuscular blockade for endotracheal intubation and require active reversal of neuromuscular blockade.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 115
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 5

排除标准

  • Subjects with neuromuscular disorders that may affect neuromuscular blockade and/or assessments will be excluded from this study, in addition subjects who cannot meet general standards for anaesthesia trials (inability to intubate, renal/hepatic dysfunction, allergies to general anaesthesia medications, malignant hyperthermia, interactions with toremifene/fusidic acid, pregnant patients, previous enrollment in trials or relation to staff) will also be excluded.

研究者

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