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临床试验/NCT05320016
NCT05320016已完成不适用

Effects of Remimazolam Combined With Remifentanil on Quality of Recovery After Ambulatory Hysteroscopic Surgery: a Prospective, Observational Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年11月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Quality of recovery

研究概览

简要总结

Remimazolam is a novel ultra-short acting benzodiazepine with rapid onset of effects, short maintenance and faster recovery time. Due to its recent development, few studies have investigated the effect of remimazolam on postoperative recovery mainly focusing on physiologic endpoints, recovery time and possible adverse events. Although these parameters are crucial and need evaluation, the investigators ignore quality of recovery from participant's perspective. For this purpose, various measurment tools have been developed for psychometric evaluation of QoR score.

详细描述

To date, there has not been a study investigating the impact of remimazolam on quality of recovery (QoR). This study evaluates the effect of remimazolam on QoR of participants undergoing general anesthesia using remimazolam-remifentanil total intravenous anesthesia (TIVA) for hysteroscopy as day surgery basis. Herein, the investigators used the translated Korean version of the 15-item Quality of Recovery-15 (QoR-15K) questionnaire, which was previously validated in Korean surgical participants.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult woman scheduled for ambulatory gynecological surgery under general anesthesia
  • American Society of Anesthesiology grade 1 or 2

排除标准

  • Underlying diseases: liver, kidney, brain nervous system, glaucoma
  • Patients with BMI greater than 30 and less than 18.5
  • Patients diagnosed with sleep apnea
  • Alcohol or drug dependent patients
  • Patients with severe or acute respiratory failure
  • Lactose intolerance
  • Dextran 40 hypersensitivity
  • Patients in shock or coma

结局指标

主要结局

Quality of recovery

时间窗: 24 hours after ambulatory hysteroscopic surgery

the translated Korean version of 15-item Quality of Recovery scale (QoR-15K)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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