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临床试验/NCT06136585
NCT06136585招募中3 期

Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月1日最近更新:
适应症
干预措施

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

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

Experimental

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

Active Comparator

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryu Komatsu

MD

The Cleveland Clinic

研究点 (1)

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