Recovery After Laparoscopic Hysterectomy With Deep Neuromuscular Blockade and Low Intra-abdominal Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Shoulder Pain
研究概览
简要总结
The purpose of this study on laparoscopic hysterectomy is to investigate postoperative pain. Patients are allocated to either deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) or moderate neuromuscular blockade and usual intra-abdominal pressure (12 mmHg).
Primary hypothesis:
Deep neuromuscular blockade and low intra-abdominal pressure (8 mmHg) reduces postoperative pain compared to moderate neuromuscular blockade and intra-abdominal pressure (12 mmHg).
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
- 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
- •Elective laparoscopic hysterectomy (total/subtotal)
- •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
- •Impaired liver function
- •Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)
研究组 & 干预措施
Deep neuromuscular blockade
Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron
干预措施: Rocuronium (Drug)
Moderate neuromuscular blockade
Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron
干预措施: placebo (Drug)
结局指标
主要结局
Shoulder Pain
时间窗: within 14 days
Number of participants with shoulder pain or discomfort (VAS \> 20) in the shoulder region within 14 days after operation. VAS 0-100: Visual analouge scale for assessment of pain ranging from no pain (value 0) to worst kind of pain (value 100).
次要结局
- Pain (Assessed on a 0-100 Visual Analouge Scale (VAS): 0 no Pain, 100 Worst Kind of Pain)(within 14 days)
研究者
Matias Vested Madsen
research assistent, MD
Herlev Hospital