A Randomized Controlled Double-blinded Trial Comparing the Effect of on Demand vs Deep Neuromuscular Relaxation on Rating of Surgical and Anesthesia Conditions in Patients Undergoing Thoraco-laparoscopic Esophagectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Rating of surgical conditions (SRS) during the abdominal phase of the operation.
研究概览
简要总结
Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia conditions. Under these conditions, boluses of muscle relaxants can be given on indication only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex are needed to reverse NMB at the end of surgery.
Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed in both groups in an economical perspective and to compare the intra-operative cardiac and respiratory incidents and post-operative complication rate of both groups.
Study design: a single-center randomized controlled double-blinded intervention study.
Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal resection.I Intervention: Patients are randomized to receive either continuous infusion of rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.
Main study parameters/endpoints: The primary outcome parameter of this study is the SRS during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
- •Written informed consent
排除标准
- •pregnancy
- •Known allergies for aminosteroid-type muscle relaxants or sugammadex.
- •Severe kidney dysfunction (GFR < 30), patients on dialysis
- •Liver function disorders
- •Myasthenia Gravis or other (neuro)muscular diseases
- •Patients with carcinomatosis
- •Use of anti-epileptics and lithium or drugs containing Kinin
研究组 & 干预措施
deep neuromuscular relaxation
continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon
干预措施: Rocuronium (Drug)
结局指标
主要结局
Rating of surgical conditions (SRS) during the abdominal phase of the operation.
时间窗: during operation
次要结局
- Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.(during operation and an average of 4 weeks thereafter)
- Rating of SRS during thoracic phase of the operation.(during operation)
- Number of on demand boluses infused, indication of on demand bolus administration(during operation)
- Number of correct estimates of group randomization by surgeons(directly after operation)
- Rating of anesthesia conditions(during operation)
研究者
D.P.Veelo
MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)