A Randomized Controlled Trial to Compare the Effectiveness of Deep vs. Moderate Neuromuscular Blockade in Reducing Postoperative Pain and Intra-Abdominal Insufflation Pressure During Minimally Invasive Robotic Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
研究概览
简要总结
The purpose of this study is to determine if there is a difference in intra-abdominal pressure which surgeons use during surgery and post-surgery pain in men who undergo robotic prostate surgery with deep neuromuscular blockade (NMB), compared with moderate NMB.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients under the age of 80
- •American Society of Anesthesiologists Physical Status 1, 2,
- •Elective Robotic Prostatectomy
- •Patient undergoing surgery at Josie Robertson Surgical Center
排除标准
- •Age younger than 18
- •Inability to provide informed consent
- •Allergy to rocuronium, sugammadex, midazolam, propofol, fentanyl, lidocaine, mannitol (IV Acetaeminophen), IV Acetaminophen, Ketorolac, Morphine, Hydromorphone, Dexamethasone, Zofran, Benadryl, Compazine
- •Neuromuscular disease
- •Any patient with previous abdominal surgery less than or equal to 20 years prior to scheduled surgery date
- •Patients with BMI>35
- •Severe renal impairment (Creatinine clearance < 30 ml/min)
- •Patient receiving Toremifene or any history of receiving Toremifene
- •Chronic pain patients
- •Patients receiving suboxone
- •Patients receiving succinylcholine
研究组 & 干预措施
Interventional Group: Deep Neuromuscular Blockade
The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).
干预措施: Rocuronium 1.5mg/kg/hr (Drug)
Control Group: Moderate Neuromuscular Blockade
The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).
干预措施: Rocuronium 0.3mg/kg/hr (Drug)
结局指标
主要结局
Mean Difference in Intra-Abdominal Pressure (IAP) When Performing Robotic Prostatectomy in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique
时间窗: 6 hours post operation
Measured by continuous Intra-abdominal Pressure monitor in mmHg.
Difference in Levels of Postoperative Pain in Participants Under a Moderate vs Deep Neuromuscular Blockade Technique During Robotic Prostatectomy Using the Pain Numeric Pain Scale (NPS).
时间窗: 6 hours post operation
Difference in levels of postoperative pain in participants under a moderate vs deep Neuromuscular Blockade technique during robotic prostatectomy using the pain numeric pain scale (NPS). The numeric pain scale (NPS) is a subjective measure which can be used in recovery rooms to assist in the assessment of pain. Individuals rate their pain on an eleven-point scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
次要结局
未报告次要终点