The Effectiveness of Deep Versus Moderate Muscle Relaxation During Laparoscopic Donor Nephrectomy in Enhancing Postoperative Recovery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)
研究概览
简要总结
Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The investigators' goal is to establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) and the early quality of recovery. Therefore, the investigators designed a trial in which patients scheduled for living donor nephrectomy are randomized into a group with deep NMB or moderate NMB. The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.
详细描述
Rationale: Postoperative recovery after live donor nephrectomy (LDN) is largely determined by the consequences of postoperative pain and analgesia consumptions. The use of deep neuromuscular blockade (NMB) has shown to reduce postoperative pain scores after laparoscopic surgery. With this study the investigators will investigate if deep NMB also improves the early quality of recovery after LDN.
Objective: To establish the relationship between the use of deep neuromuscular blockade (NMB) during laparoscopic donor nephrectomy (LDN) - with standard pressure pneumoperitoneum - and the early quality of recovery.
Study design: A multicenter, blinded, randomized controlled trial
Study population: 96 adult patients (18 years or older), scheduled for living donor nephrectomy, will be randomized into a group with deep or moderate neuromuscular blockade. Deep neuromuscular blockade is defined as post tetanic count 1-2.
Main study parameters/endpoints: The primary outcome measurement will be the Quality of Recovery-40 questionnaire (overall score) at 48 hours after extubation.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •obtained informed consent
- •age over 18 years
排除标准
- •insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
- •chronic use of analgesics or psychotropic drugs
- •use of NSAIDs shorter than 5 days before surgery
- •known or suspect allergy to rocuronium of sugammadex
- •neuromuscular disease
- •indication for rapid sequence induction
- •deficiency of vitamin K-dependent clotting factors, coagulopathy or active use of coumarin derivates.
- •Peri-operative use of fusidic acid or flucloxacillin
- •Severe renal impairment (creatinine clearance <30ml/min)
- •Morbid obesity (BMI>35 kg/m2)
结局指标
主要结局
Total Score of the Quality of Recovery-40 Questionnaire (QoR-40)
时间窗: Day 1: 24 hours after detubation
The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200. Higher values represent a better outcome
次要结局
- Conversion(Day 0: once, up to 240 minutes)
- Surgical Conditions(Day 0: Intraoperative, average of scores up to 240 minutes (assessed each 15 minutes))
- Warm Ischemia Time(Day 0: once, up to 240 minutes)
- Postoperative Complications(24 and 48 hours (and if still admitted 72h) after detubation and 4 and 8 weeks after surgery)
- Cumulative Use of Rocuronium(Day 0: once, up to 240 minutes)
- Total Score of the Quality of Recovery-40 Questionnaire(Day 2: 48 hours after detubation)
- Postoperative Pain(Day 0: 1h, 6h, day 1: 24h and day 2: 48 hours (and if still admitted 72h) after detubation)
- Length of Pneumoperitoneum(Day 0: once, up to 240 minutes)
- Estimated Blood Loss(Day 0: once, up to 240 minutes)
- Intra-operative Complications(Day 0: once, up to 240 minutes)
- Discharge Criteria(24 and 48 hours after detubation)
- Pain Scores(once, 4 weeks after surgery)