Comparison of Two Neuromuscular Anesthetics Reversal in Obese Patient Undergoing Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine.
研究概览
简要总结
The study is a prospective, single center, double arm study aiming at the comparison of 2 commercial neuromuscular block reversal drugs: Neostigmine (Cooper S.A.) and Sugammadex (MSD). A faster recovery from neuromuscular block is expected for patients receiving Sugammadex and this protocol is of high importance for anesthesia of morbid obese patients during bariatric surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Morbidly obese male or female patients in the age 20-65 that are candidates for bariatric surgery.
- •Patients that can read and understand the fundamental nature of the clinical protocol.
- •Patients must sign the Informed Consent Form.
排除标准
- •Patients treated with drugs that might interact with Rocuronium.
- •Patients with history of malignant hyperthermia.
- •Patients with significant renal disease.
- •Patients with a known allergy to one of the drugs used during anesthesia.
- •Patients with known muscular disease.
- •Patients with severe cardiovascular disease (NYHA>2)
- •Breast feeding patients
- •Patients refusing to follow the clinical protocol.
- •Patients participating in a different clinical trial.
- •Patients refusing to sign the Informed Consent Form
- •Physician's objection.
研究组 & 干预措施
Patients recieving Sugammadex
Sugammadex Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Sugammadex 2.0 mg/kg body.
干预措施: Sugammadex vs. Neostigmine (Drug)
Patients recieving Neostigmine
Neostigmine Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Neostigmine 0.05 mg/kg body and atropine 0.1 mg/kg body.
干预措施: Sugammadex vs. Neostigmine (Drug)
结局指标
主要结局
Safety of Sugammadex reversal - number of drug-related adverse events with Sugammadex <= that of Neostigmine.
时间窗: Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery)
The number of drug-related adverse events using Sugammadex is smaller or equal to those using Neostigmine.
次要结局
- Use of Sugammadex for neuromuscular anaesthesia reversal higher patient satisfaction compared to Neostigmine.(Monitoring nueromuscular reaction from end of anesthesia recovery (in the OR) intil patient is released from hospital (48-72 h post surgery))