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临床试验/NCT03144453
NCT03144453Unknown4 期

Recovery From Anesthesia After Robotic Assisted Radical Cystectomy. Two Different Reversal of Neuromuscular Blockade

Regina Elena Cancer Institute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年5月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
50
试验地点
2
主要终点
Time to discharge from recovery room

研究概览

简要总结

Robot-assisted radical cystectomy (RARC) requires specific surgical conditions: steep Trendelenburg position, prolonged pneumoperitoneum, effective neuromuscular block until the final stages of surgery. The aim of this study was to evaluate the quality of awakening in two groups of patients undergoing different combinations of curarization/reversal.

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

入选标准

  • ASA (american society of anesthesiologists) score ≤ III
  • Patients underwent robotic assisted cystectomy

排除标准

  • Cerebrovascular disease
  • BMI (body mass index) ≥ 30

研究组 & 干预措施

Sugammadex

Experimental

The patients received sugammadex as neuromuscular blockade reversal

干预措施: Sugammadex Injectable Product (Drug)

Standard

Active Comparator

The patients received neostigmine + atropine as neuromuscular blockade reversal

干预措施: Neostigmine, Atropine (Drug)

结局指标

主要结局

Time to discharge from recovery room

时间窗: Up to 240 Minutes After recovery

Time between reversal administration and discharge from the recovery room

次要结局

未报告次要终点

研究者

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

Ester Forastiere

MD

Regina Elena Cancer Institute

研究点 (2)

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