Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time required from reversal of neuromuscular block to discharge readiness
研究概览
简要总结
The investigators propose a single-center, assessor-Blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Fairview Hospital.
详细描述
The investigators propose a single-center, assessor-blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine. Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who assume anesthesia care will not be blinded to group assignment.
American Society of Anesthesiologists (ASA) physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Fairview Hospital will be included in the study. Patients will be excluded if they have suspected difficult airway, neuromuscular disorders, end-stage renal disease requiring hemodialysis, are allergic to fentanyl, neuromuscular blocking drugs or neuromuscular reversal drugs, or are pregnant or breastfeeding.
Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 1:1 to: 1) reversal by sugammadex; or 2) reversal by neostigmine. Randomization will be stratified by 2 factors: (1) patient's age (older than 60 versus younger than 60) and (2) diagnostic vs. interventional procedures. Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia, thus concealing allocation so long as practical.
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)
盲法说明
A single-center, Assessor-Blinded, parallel group randomized trial
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
- •≥18 years old
- •American Society of Anesthesiologist physical status 3-4
- •Scheduled for outpatient endoscopic retrograde cholangiopancreatography
排除标准
- •Difficult Airway
- •Neuromuscular Disorders (eg: ALS, Botulism, Myasthenia Gravis, Lambert-eaton syndrome)
- •End stage renal disease requiring dialysis
- •Pregnancy or breast-feeding
- •Allergy to Fentanyl
- •Allergy to Neuromuscular blocking drugs (eg: rocuronium)
- •Allergy to Neuromuscular reversal drugs (eg: sugammadex or neostigmine)
- •Allergy to glycopyrrolate
研究组 & 干预措施
2 mg/kg sugammadex
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex.
干预措施: 2 mg/kg sugammadex (Drug)
0.07 mg/kg neostigmine
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg).
干预措施: 0.07 mg/kg neostigmine (Drug)
结局指标
主要结局
Time required from reversal of neuromuscular block to discharge readiness
时间窗: First 24 hours after reversal of neuromuscular block
To assess the time required from reversal of neuromuscular block to discharge readiness in patients randomized to sugammadex or neostigmine.
次要结局
- Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.(2 hours of post anesthetic recovery)
