Effect of an Induction Dose of Non Depolarizing Neuro Muscular Blocking Agents (NMBA) on Ultrasound Bowel Peristalsis.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proportion of patients with a score of motion = 0
研究概览
简要总结
Phase III prospective randomised study : curare vs placebo, comparing bowel peristalsis (abdominal echography) in the first minutes of after general anesthesia induction.
Primary End Point: proportion of patients with a score of motion = 0
详细描述
Primary End Point Proportion of patients with a score of motion = 0
Secondary End Point Time at which thumb adductor twitch measurement disappears (3rd consecutive measure with a twitch at 0) Mean minimal twitch measurement for those patients in who twitch measurement does not disappear Concordance study between twitch measurement and bowel peristalsis XML File Identifier: 1vUwHz2uUXeSc7soLu1cQwRAfcM= Page 15/24 ultrasound score.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery
- •scheduled oro tracheal intubation
排除标准
- •Counter indication to NMBA:
- •predicted difficult airway
- •surgical counter indication: facial or laryngeal nerve function monitoring
- •allergy to muscle relaxants neuro muscular disease Possible alteration of sensitivity to muscle relaxants due to ongoing medication: ex Valproate or aminoglycoside antibiotics. Predictable alteration of bowel movements or difficult abdominal ultrasound:
- •scheduled abdominal surgery
- •abdominal surgery in last month
- •obesity: body mass index over 30 Full stomach or pregnancy requiring suxamethonium for intubation
研究组 & 干预措施
Atracurium
injection of NMBA 0.5 mg/kg milligram(s)/kilogram in Intravenous bolus use
干预措施: injection of NMBA (Drug)
ROCURONIUM
injection of NMBA 0.6 mg/kg milligram(s)/kilogram in Intravenous bolus
干预措施: injection of NMBA (Drug)
placebo
injection of placebo Injection in Intravenous bolus use
干预措施: injection of placebo (Drug)
结局指标
主要结局
Proportion of patients with a score of motion = 0
时间窗: 10 minutes after NMBA or placebo injection
Proportion of patients with a score of motion = 0
次要结局
- Time at which thumb adductor twitch measurement disappears(1 month after injection)