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临床试验/NCT05356091
NCT05356091已完成不适用

Comparison of Postoperative Recovery Quality Between Sevoflurane and Remimazolam for General Anesthesia for Transurethral Resection of Bladder Tumor

Kangbuk Samsung Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年12月2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
发起方
入组人数
36
试验地点
1
主要终点
Quality of recovery -15 score at postoperative day 1

研究概览

简要总结

This study was designated to investigate the quality of recovery after transurethral bladder resection. Because, patients undergoing transurethral bladder resection are mostly old age, and because of catheter-related bladder discomfort are common after transurethral bladder resection, study on the quality of recovery after transurethral bladder resection seems to be meaningful. In general, sevoflurane is commonly used as an anesthetic agent for general anesthesia of transurethral bladder resection. The purpose of this study is to investigate whether remimazolam is not inferior to sevoflurnane in terms of quality of recovery after transurethral bladder resection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • adult patients aged from 19 years
  • Americaln Society of Anesthesiologist's class I, II, and III
  • scheduled to undergo elective transurethral bladder resection under general anesthesia

排除标准

  • refuse to participate in the study
  • cannot read, or sign the consent form (e.g., iliterate, foreigner, eye disease)
  • history of allergy to benzodiazepines
  • decreased liver, kidney, or heart function
  • pregnant women or breastfeeding patients
  • history of drug or alcohol abuse
  • obesity (body mass index > 30kg/m2)

研究组 & 干预措施

Sevoflurane

Active Comparator

General anesthesia using sevoflurane

干预措施: Sevoflurane (Drug)

Remimazolam

Experimental

General anesthesia using remimazolam

干预措施: Remimazolam (Drug)

结局指标

主要结局

Quality of recovery -15 score at postoperative day 1

时间窗: postoperative day 1

Quality of recovery-15 questionnaire, which consists 15 questions. The score ranges from 0 to 150. The higher the score, the better the quality of recovery.

次要结局

  • Catheter related bladder discomfort(5 minutes, and 1 hour after post-anesthesia circuit unit arrival.)

研究者

发起方
Kangbuk Samsung Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eunah Cho, MD

Assistant Professor

Kangbuk Samsung Hospital

研究点 (1)

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