A Randomized, Blinded-assessor, Single Center Study to Determine if Administration of Sugammadex, When Used to Reverse Deep Neuromuscular Blockade (NMB) After Open Abdominal Surgery, Impacts Hospital Efficiency
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Sugammadex in rapidly reversing deep neuromuscular blockaded (induced by rocuronium)
详细描述
Participants in the study group will receive a single bolus of Sugammadex (4.0mg/kg) prior to extubation. In the post-anesthesia care unit (PACU), a blinded safety-assessor will use the visual analog scale to clinically assess post-operative pain. Post-operative nausea and vomiting (PONV) will be assessed using a PONV rating scale every 30 minutes until PACU discharge. All patients will be monitored with continuous pulse-oximetry.
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)
盲法说明
Participants, Care Providers, Investigators, and Outcome Assessors are blinded from the type of NMBA reversal agent used prior to completion of data collection
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 scheduled for open ventral hernia repair or open colectomy
- •ASA class I-III
- •18 years and older
- •Subjects with a body mass index (BMI) of <45kg/m2 and weight less than 150kg
- •Subjects who have given written informed consent
排除标准
- •Subjects with medical conditions and/or undergoing surgical procedures that are not compatible with the use of the TOF-Watch® SX (e.g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemaker
- •Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
- •Subjects known or suspected to have significant renal dysfunction (e.g. creatinine clearance < 30 mL.min-1
- •Subjects known or suspected to have a (family)history of malignant hyperthermia; have significant hepatic dysfunction
- •Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other medications used during general anesthesia;
- •Subjects known or suspected to be hypersensitive to Sugammadex or other cyclodextrins or Rocuronium or any of its excipients
- •Subjects who have a contraindication to, Rocuronium or Sugammadex
- •Female subjects who are pregnant
- •Morbidly obese subjects with a BMI > 45 kg/m2 or weight more than 150 kg
研究组 & 干预措施
Neostigmine + Glycopyrrolate
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
干预措施: Neostigmine (Drug)
Neostigmine + Glycopyrrolate
Neostigmine 0.06 mg/kg and Glycopyrrolate 0.04mg/kg iv
干预措施: Glycopyrrolate (Drug)
sugammadex
Sugammadex 4mg/kg
干预措施: sugammadex (Drug)
结局指标
主要结局
Operating Room (OR) Turnover Time When Using Sugammadex Instead of Combination of Neostigmine and Glycopyrrolate.
时间窗: through start of next surgery, average of 2 hours
次要结局
- Number of Patients Who Experience Postoperative Nausea and Vomiting, Post-operative Pain, and Post-operative Complications(through discharge from hospital, average of 72 hours)
研究者
Enrico Camporesi
Attending Anesthesiologist & Director of Research, SE
University of South Florida