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临床试验/NCT02562417
NCT02562417撤回4 期

Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Mean recovery time for T4/T1 ratio > 90% after sugammadex administration

研究概览

简要总结

Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.

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
Triple (Participant, Care Provider, Investigator)

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

  • patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures

排除标准

  • contraindication to dexamethasone administration
  • contraindication to sugammadex administration
  • contraindication to rocuronium administration

研究组 & 干预措施

No IV dexamethasone

Placebo Comparator

Patients will receive an equivalent volume of normal saline.

干预措施: Normal saline (Drug)

IV dexamethasone

Experimental

Patients will receive 0.1 mg/kg of dexamethasone.

干预措施: IV dexamethasone (Drug)

结局指标

主要结局

Mean recovery time for T4/T1 ratio > 90% after sugammadex administration

时间窗: surgical procedure

次要结局

  • Mean recovery time for T4/T1 ratio > 70% after sugammadex administration(surgical procedure)
  • Mean recovery time for T4/T1 ratio > 80% after sugammadex administration(surgical procedure)

研究者

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

Eric Albrecht

Program Director, Regional Anaesthesia

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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