The Role of Deep Neuromuscular Blockade and Sugammadex in Laparoscopic Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Overall pain in the first 24 hrs after gynecologic surgical procedures
研究概览
简要总结
The primary outcome of this study is to investigate whether deep NMB reversed with Sugammadex is superior to moderate NMB reversed with Neostigmine, in terms of overall pain in the first 48 hrs after laparoscopic hysterectomy, reversal time from NMB (TOF≥0.9) and direct and indirect costs. Additionally we will also assess: drugs consumption for pain and antiemetics (rescue dose), surgical conditions, hemodynamic and respiratory stability, operation time, anesthesia time, total amount and flow rate of CO2, insufflation time, resolution of post-operative ileus, dry mouth and PONV in the first 48 hours, patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Anesthesiologists were aware of the treatment assignment, while the surgeon and surgical staff were blinded. Additionally, patients, nurses/doctors assessing outcomes, and the statistician were blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years BMI between 16 and 40 Kg/m2 ECOG Performance Status tra 0 e 1 American Society Anesthesiologist (ASA) class 1 or 3 Able to provide informed consent to trial procedures
排除标准
- •Age < 18 or > 75 years
- •BMI <16 o > 40 Kg/m2
- •ECOG Performance Status >1
- •Pregnancy
- •Active or recent pelvic inflammation
- •Anticipated airway difficulty
- •Patients with history of allergy to rocuronium, neostigmine or sugammadex
- •Allergy to NSAIDs
- •Previous opioids consumption for chronic pain
- •Patients receiving drugs for different medical conditions, that may prolong or shorten the duration of rocuronium effect (e.g aminoglycosides, magnesium)
- •Hepatic or renal failure
- •Persistent coagulopathy
- •Neurological or cognitive disorders
- •Conversion from laparoscopic to open surgery Onset of intraoperative complications
研究组 & 干预措施
SUG
干预措施: Sugammadex (Drug)
NEO
干预措施: Neostigmine (Drug)
结局指标
主要结局
Overall pain in the first 24 hrs after gynecologic surgical procedures
时间窗: First 48 hrs after gynecologic surgical procedures
0-10 NRS
Recovery time (or Reversal time) from NMB (TOF≥0.9)
时间窗: Recovery time (or Reversal time) from NMB (TOF≥0.9) will be measured after the administration of reversal agent at the end of the surgical procedure.
Recovery time (or Reversal time) from NMB (TOF≥0.9), measured in minutes from to administration of reversal agent to a TOF≥0.9
次要结局
未报告次要终点
研究者
Corrado Terranova
Principal investigator
Campus Bio-Medico University