NCT03116997已完成3 期
Randomized Controlled Assessor Blinded Clinical Trial of Sugammadex Versus Neostigmine /Glycopyrrolate for Reversal of Rocuronium Induced Neuromuscular Blockade: Time to Discharge From Post Anesthesia Care Unit and Patient Satisfaction With Recovery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 4
- 主要终点
- Measure Participants' Recovery Time Post-Surgery
研究概览
简要总结
The purpose of this study is to compare two different medications (neostigmine/glycopyrrolate and sugammadex) to see if one drug improves patient comfort regarding the return of muscle strength after surgery.
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
- Double (Participant, Outcomes Assessor)
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
- •Adult patients age 18 years of age or greater who are capable of giving consent
- •Undergoing surgical procedures of expected length 6 </= hours requiring NMB
排除标准
- •Pregnancy
- •History of documented anaphylaxis or contraindication to any of the study medications
- •Active coronary disease with a positive cardiac stress test
- •History of severe chronic obstructive pulmonary disease (COPD) defined as an FEV1 < 50% of predicted
- •Serum Creatinine >/= 2.0 mg/dL
- •Severe hepatic dysfunction accompanied by coagulopathy
- •Definition:
- •Known liver Disease AND
- •INR > 1.5 (except for patients on anticoagulants) AND
- •Platelet count <100,00/ul without other obvious cause
- •Chronic sustained release opioid for > 2 weeks duration pre op (in the 30 days prior to surgery)
- •Use of toremifene
- •Significant cognitive impairment or documented psychologic impairment
- •Myasthenia gravis or other neuromuscular disease
- •Patients who are not eligible for standard anesthetic induction, eg, those needing rapid sequence induction or awake fiberoptic bronchial intubation.
- •American Society of Anesthesiologists (ASA) Status > 3
研究组 & 干预措施
Neuromuscular blockade reversed with neostigmine/gly
Experimental
干预措施: Neostigmine+glycopyrrolate (Drug)
Neuromuscular blockade reversed with sugammadex
Active Comparator
干预措施: Sugammadex (Drug)
结局指标
主要结局
Measure Participants' Recovery Time Post-Surgery
时间窗: 1 day
Determine whether SUG, as compared to NEO decreases time for patients to be ready for discharge from the PACU post-surgery.
次要结局
未报告次要终点
研究者
研究点 (4)
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