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临床试验/NCT03381209
NCT03381209已完成不适用

The Effect of Sugammadex Given Based on Ideal, Actual or Adjusted Body Weights on Reversal of Neuromuscular Blockade in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年6月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Reversal Time

研究概览

简要总结

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight.

详细描述

The aim of this study is compare the reversal of rocuronium induced neuromuscular blockade in morbidly obese patients using three doses of sugammadex; based on ideal body weight, adjusted body weight, and actual body weight. Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

Time need for extubation (time from administration of sugammadex to extubation), and duration of stay in post anesthesia care unit (PACU), will be used as secondary outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients older than 18 years and under 45 years,
  • body mass index ≥ 40 kg/m2, with indication of bariatric surgery

排除标准

  • Patients with comorbid including: neuromuscular disease, renal impairment, and patients with difficult airway were excluded from this study.

研究组 & 干预措施

Group A

Experimental

Sugammadex given in a dose of 2mg/kg based on ideal body weight

干预措施: Sugammadex (Drug)

Group B

Experimental

Sugammadex given in a dose of 2mg/kg based on adjusted body weight

干预措施: Sugammadex (Drug)

Group C

Experimental

Sugammadex given in a dose of 2mg/kg based on actual body weight

干预措施: Sugammadex (Drug)

结局指标

主要结局

Reversal Time

时间窗: 5 minutes after sugammadex administration

Reversal Time: time from administration of Sugammadex to train of four (TOF) ratio ≥ 0.9 will be used as primary outcome.

次要结局

  • duration of stay in PACU(60 minutes after admission to the PACU)
  • Time need for Extubation(10 minutes after sugammadex administration)

研究者

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

Walid Nofal

Lecturer of Anesthesiology

Ain Shams University

研究点 (1)

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