A Double-blind, Randomized, Parallel Group Study to Compare Rocuronium Reversal With Sugammadex (Bridion®) Versus Neostigmine/Glycopyrrolate and the Incidence of Urinary Retention After Elective Ambulatory Posterior Lumbar Laminectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Incidence of urinary retention
研究概览
简要总结
This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.
详细描述
Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.
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)
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
- •Age ≥ 18 years
- •ASA Physical Status I-III
排除标准
- •Inability to obtain written informed consent
- •Allergy to medications used in the protocol
- •Known or suspected neuromuscular disorders
- •Significant renal disease with a serum creatinine ≥ 2 mg/dL
- •Significant liver disease
- •A family history of malignant hyperthermia
- •History of genitourinary surgery, cancer, or radiation within the last year
- •Currently prescribed urological medications or diuretics
- •BPH or symptoms of BPH (interrupted or weak urine stream or wake up to urinate more than two times per night)
- •History or diagnosis of urinary incontinence or urinary retention
- •History of PONV with use of scopolamine
- •Use of Foley catheter pre- or intra- operatively
- •Perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than NMB reversal)
研究组 & 干预措施
Sugammadex 2 mg/kg
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.
干预措施: Sugammadex (Drug)
Neostigmine + Glycopyrrolate
Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.
干预措施: Glycopyrrolate (Drug)
Neostigmine + Glycopyrrolate
Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.
干预措施: Rocuronium (Drug)
Neostigmine + Glycopyrrolate
Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.
干预措施: Neostigmine (Drug)
Sugammadex 2 mg/kg
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Incidence of urinary retention
时间窗: Up to 6 hours after administration of study intervention
The difference between sugammadex and neostigmine/glycopyrrolate on the incidence of urinary retention defined as no void more than 6 hours after posterior lumbar spine surgery in ambulatory/short stay patients.
次要结局
- Micturition(Up to 1 day after administration of study intervention)
- Length of hospital stay(Up to 7 Days after administration of study intervention)
- Urinary retention symptoms(Up to 1 day after administration of study intervention)
- Bladder catheterization(Up to 1 Day after administration of study intervention)
- Bladder urine volume(Up to 6 hours after administration of study intervention)
研究者
Julie Marshall
Professor of Anesthesiology
University of Missouri-Columbia