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临床试验/jRCT1051220068
jRCT1051220068招募中不适用

A randomized controlled trial of the effect of remimazolam on postoperative QT interval in gynecologic laparotomy

未提供0 个研究点目标入组 120 人开始时间: 2022年9月6日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
120
主要终点
-

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Other
盲法
Open(masking Not Used)

入排标准

年龄范围
20age old over 至 No limit(—)
性别
Female

入选标准

  • Patients scheduled for genecologic laparatomy
  • under general anesthesia
  • Patients aged 20 or older
  • Patients classified as ASA-PS 1 or 2 (American Society of Anesthesiologists-Physical Status)
  • Patients who fully understand the study after sufficient explanations and provide the written volun
  • tary consent

排除标准

  • Patients who have contraindication or allergy to sevoflurane or remimazolam
  • Patients who have abnormal QT interval in preoperative ECG
  • Patients who do not have sinus rhythm in preoperative ECG
  • Patients who take antipsychotics, antiarrhythmics, or beta-blockers
  • Patients who have hypokalemia (< 3.5 mEq/L) or hyperkalemia (> 5.5 mEq/L) in preoperative labor
  • Patients whose BMI are 35 or greater
  • Patient who are considered ineligible for enrolling the study by a principal- or co-investigator

结局指标

主要结局

-

Heart-rate corrected QT (QTc) interval after tracheal extubation

次要结局

  • Correlation between plasma concentration of remimazolam and QTc
  • Correlation between plasma concentration of ropivacaine and QTc
  • QTc interval during induction of anesthesia(during induction of anesthesia)
  • Hourly QTc inteval from the beggining to the end of surgery(from the beggining to the end of surgery)
  • QTc interval at postoperative day 1(postoperative day 1)
  • Incidecne of perioperative fatal arrhythmia through medical record review(perioperative)

研究者

发起方
未提供

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