Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Intraabdominal Distance (Centimeters)
研究概览
简要总结
To investigate if deep neuromuscular blockade improves intraabdominal volume compared to no neuromuscular blockade in patients scheduled for gynecologic laparoscopic surgery with pneumoperitoneum 12 mmHg.
Hypothesis:
Deep neuromuscular blockade improves intraabdominal space (the distance from promontorium to skin surface, cm) compared to no neuromuscular blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients > 18 years old
- •elective laparoscopic operation
- •can read and understand Danish
- •informed consent
排除标准
- •BMI > 30 kg/cm2
- •known allergy to medications that are included in the project,
- •severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis),
- •neuromuscular disease that may interfere with neuromuscular data,
- •lactating or pregnant,
- •impaired liver function,
- •converting to laparotomy,
- •perioperative use of neuromuscular blocking agents before randomization,
- •pneumoperitoneum set to >12 mmHg on the insufflator
研究组 & 干预措施
Deep neuromuscular block followed by no neuromuscular block
Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
干预措施: rocuronium (Drug)
Deep neuromuscular block followed by no neuromuscular block
Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
干预措施: sugammadex (Drug)
Deep neuromuscular block followed by no neuromuscular block
Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.
Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade
干预措施: placebo (Drug)
No neuromuscular block followed by deep neuromuscular block
No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: rocuronium (Drug)
No neuromuscular block followed by deep neuromuscular block
No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: sugammadex (Drug)
No neuromuscular block followed by deep neuromuscular block
No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.
Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.
干预措施: placebo (Drug)
结局指标
主要结局
Intraabdominal Distance (Centimeters)
时间窗: 1 hour
Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 12 mmHg with and without deep neuromuscular blockade (PTC 0-1).
次要结局
- Intraabdominal Distance (Centimeters)(1 hour)
- Surgical Conditions During Suturing of the Abdominal Fascia(1 hour)
研究者
Matias Vested Madsen
research assistent, MD
Herlev Hospital