EUCTR2012-001886-33-FI进行中（未招募）不适用
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, P07982) - Effects of Depth of Neuromuscular Blockade and Insufflation Pressure on Surgical Conditions
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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 meeting general standards for anesthesia trials (inability to intubate, renal/hepatic dysfunction, allergies to general anesthesia 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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Effects of Depth of Neuromuscular Blockade and Insufflation Pressure on Surgical Conditions.Patients undergoing elective in-patient laparoscopic cholecystectomy procedures under general anesthesia with neuromuscular relaxation and active reversal of neuromuscular blockade.MedDRA version: 14.1 Level: LLT Classification code 10018061 Term: General anesthesia System Organ Class: 100000004865EUCTR2012-001886-33-ITMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.127
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