NCT04076709已完成不适用
The Impact of Neuromuscular Relaxation and Nociception Guided Anaesthesia on Hemodynamic Variables During Lower Abdominal Laparoscopic Surgery: a Strategy Trial.
Leiden University Medical Center1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Many surgical procedures are performed using the laparoscopic approach. However, insufflation of the abdomen (pneumoperitoneum) has detrimental hemodynamic effects. The investigators intend to investigate the effect of deep neuromuscular block and nociception guided anaesthesia on hemodynamic variables during pneumoperitoneum for lower abdominal laparoscopic surgery.
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, Outcomes Assessor)
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
- •Scheduled for lower laparoscopic abdominal surgery;
- •Ability to give oral and written consent;
排除标准
- •Known or suspected neuromuscular disorders impairing neuromuscular function;
- •Allergies to muscle relaxants, anesthetics or narcotics;
- •A (family) history of malignant hyperthermia;
- •Women who are or may be pregnant;
- •Preexisting cardiac disease (any);
- •Untreated or uncontrolled hypertension;
- •COPD gold 3 or higher
- •Preexistent esophageal pathology (stricture, tumor, diverticulum)
- •Any increased risk factor for upper gastro intestinal tract bleed:
- •History of GI surgery;
- •History of GI bleed;
- •Esophageal varices;
- •Gastric or esophageal inflammation;
- •Severe thrombocytopenia (less than 50k) or severely elevated INR (>4).
结局指标
主要结局
Blood pressure
时间窗: 30 minutes after installation of pneumoperitoneum
Mean arterial pressure
次要结局
- Blood pressure(60 minutes after installation of pneumoperitoneum)
- Cardiac output(60 minutes after installation of pneumoperitoneum)
研究者
Martijn Boon
Principle Investigator
Leiden University Medical Center
研究点 (1)
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