Muscle Relaxation During Open Upper Abdominal Surgery - Can the Surgical Conditions be Optimized?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Surgical Rating Score
研究概览
简要总结
The depth of neuromuscular blockade (NMB) during surgery may cause a clinical dilemma between optimal surgical conditions and the risk of postoperative residual blockade.
The aim of the study is to investigate if intense NMB improves surgical conditions during operation in patients scheduled for elective open upper abdominal 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
- Single (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
- •Patients > 18 years old
- •Elective open upper abdominal surgery
- •Can read and understand Danish
- •Informed consent
排除标准
- •Known allergy to rocuronium or sugammadex
- •Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis
- •Neuromuscular disease that may interfere with neuromuscular data
- •Abdominal mesh with size larger than 5*5 cm
- •Lactating or pregnant
研究组 & 干预措施
Standard neuromuscular blockade
Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).
干预措施: Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo). (Drug)
Deep neuromuscular blockade
Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.
干预措施: Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment. (Drug)
结局指标
主要结局
Surgical Rating Score
时间窗: After randomization every 30 minutes during the operation from first incision to last suture of fascial closure, up to 300 minutes
The final score for the surgical conditions of a patient defined as the average of all scores provided during the surgical procedure. (Rated on a 5 point subjective rating scale; 1: extremely poor, 2: poor, 3: acceptable, 4: good, 5: optimal)
次要结局
- The Surgical Rating Score During Fascial Closure(Immediatly after fascial closure)
研究者
Matias Vested Madsen
MD, research assistant
Herlev Hospital