MRI Measurement of the Effects of Moderate Versus Deep Neuromuscular Blockade on the Abdominal Working Space During Laparoscopic Surgery in a Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 主要终点
- Abdominal working space
研究概览
简要总结
During laparoscopy, a surgical working space is obtained by creation of a pneumoperitoneum. Optimal surgical conditions are essential to ensure the patient's safety. A meta-analysis on studies comparing the influence of deep and moderate neuromuscular blockade (NMB) on the quality of the surgical space conditions during laparoscopy (1), showed that compared to moderate NMB, deep neuromuscular blockade improves the surgical space conditions, assessed by the Leiden-Surgical Rating scale, as reported by Martini and colleagues (2).
In this prospective cohort study, we will assess the influence of deep neuromuscular blockade on the surgical space, measured by magnetic resonance imaging (MRI) in patients scheduled for laparoscopic donor nephrectomy
详细描述
Objective: To establish the influence of deep neuromuscular blockade (NMB) on the abdominal working space during laparoscopy.
Study design: A single center prospective cohort study
Study population: 10 adult patients (18 years or older), equally distributed by gender, scheduled for laparoscopic donor nephrectomy
Study procedures:
Induction of general anesthesia followed by intubation and creation of a pneumoperitoneum (12 mmHg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 laparoscopic donor nephrectomy
- •obtained informed consent
排除标准
- •Unable to provide informed consent
- •known or suspect allergy to mivacurium, rocuronium or sugammadex
- •neuromuscular disease
- •indication for rapid sequence induction
- •Being unable to undergo MRI due to any reason (e.g. non MRI-compatible implants, epilepsy)
- •BMI>30 kg/m2
- •American Society of Anesthesiologists (ASA) classification >2
研究组 & 干预措施
No Rocuronium
Phase 1: no neuromuscular blockade
干预措施: No Rocuronium (Procedure)
Rocuronium (moderate NMB)
Phase 2: moderate neuromuscular blockade (TOF 1-3)
干预措施: Rocuronium (moderate NMB) (Drug)
Rocuronium (deep NMB)
Phase 3: deep neuromuscular blockade (PTC 0-1)
干预措施: Rocuronium (deep NMB) (Drug)
结局指标
主要结局
Abdominal working space
时间窗: 3 times (phase 1 (no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes
Skin-sacral promontory distance, measured by MRI
次要结局
- Abdominal volume(3 times (phase 1 no neuromuscular blockade, phase 2 moderate neuromuscular blockade, phase 3 deep neuromuscular blockade. From start of surgery until third scan, total duration of 30 minutes)