Optimizing Surgical Conditions During Gynecologic Laparoscopic Surgery With Deep Neuromuscular Blockade
Optimizing Surgical Conditions: Intraabdominal Distance During Gynecologic Laparoscopic Surgery With and Without Muscle Relaxation (The Measurement Study)
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Søborg
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Copenhagen、Søborg、丹麦、2830
- Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients > 18 years old
- elective laparoscopic operation
- can read and understand Danish
- informed consent
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：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 |
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安慰剂比较：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraabdominal Distance (Centimeters)
大体时间：1 hour
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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).
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1 hour
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraabdominal Distance (Centimeters)
大体时间：1 hour
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Difference in intraabdominal distance from promontorium to the edge of the trocar in umbilicus at 8 mmHg with and without deep neuromuscular blockade (PTC 0-1).
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1 hour
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Surgical Conditions During Suturing of the Abdominal Fascia
大体时间：1 hour
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Optimal (score 1) Good (score 2) Acceptable (score 3) Poor (score 4)
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1 hour
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合作者和调查者
调查人员
- 首席研究员：Matias Vested Madsen, MD、Department of Anesthesiology Herlev Hospital
- 研究主任：Olav Istre, MD, DMSc, professor、Department of minimal invasive gynecology, Aleris-Hamlet, Copenhagen
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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