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临床试验/NCT02534623
NCT02534623Unknown不适用

Postoperative Quality of Recovery After Transurethral Resection of the Bladder: Spinal Versus General Anesthesia

General Hospital Zadar1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
Quality of Recovery 40 (QoR-40)

研究概览

简要总结

Transurethral resection of the bladder (TURB) is often performed as an outpatient procedure so high-quality postoperative recovery is particularly important. The aim of this study is to compare postoperative quality of recovery after spinal anesthesia (SA) and general anesthesia (GA) for transurethral resection of the bladder.

详细描述

After written informed consent is obtained seventy patients aged 18-80 years, ASA (American Society of Anesthesiologists) physical status class I-III scheduled for TURB will be randomly assigned to either spinal anesthesia or general anesthesia. Spinal anesthesia will be performed with 12.5 mg of bupivacaine mixed with 25 mcg of fentanyl. General anesthesia will be performed with propofol and fentanyl and maintained with sevoflurane, without use of neuromuscular blocking agents. Quality of Recovery 40 questionnaire (QoR-40) administered before and 24 hours after surgery will be used for assessment of postoperative recovery.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Transurethral resection of the bladder
  • Age 18 to 80 years
  • ASA I-III

排除标准

  • Contraindications for spinal anesthesia
  • Chronic pain with use of opioids in the last week
  • Psychiatric disorders
  • Allergy to medications used in the study

研究组 & 干预措施

General anesthesia

Active Comparator

Transurethral resection of the bladder performed under general anesthesia.

干预措施: General anesthesia (Procedure)

General anesthesia

Active Comparator

Transurethral resection of the bladder performed under general anesthesia.

干预措施: fentanyl (Drug)

Spinal anesthesia

Active Comparator

Transurethral resection of the bladder performed under spinal anesthesia.

干预措施: Spinal anesthesia (Procedure)

Spinal anesthesia

Active Comparator

Transurethral resection of the bladder performed under spinal anesthesia.

干预措施: bupivacaine (Drug)

Spinal anesthesia

Active Comparator

Transurethral resection of the bladder performed under spinal anesthesia.

干预措施: fentanyl (Drug)

General anesthesia

Active Comparator

Transurethral resection of the bladder performed under general anesthesia.

干预措施: propofol (Drug)

General anesthesia

Active Comparator

Transurethral resection of the bladder performed under general anesthesia.

干预措施: sevoflurane (Drug)

结局指标

主要结局

Quality of Recovery 40 (QoR-40)

时间窗: 24 hours

Quality of Recovery 40 questionnaire at 24 hours

次要结局

  • Patient satisfaction with anesthesia measured with numerical rating scale(24 hours)
  • Postoperative opioid consumption(24 hours)
  • Postoperative pain measured with visual analogue scale(1,6 and 24 hours)

研究者

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

Nina Sulen

Anesthesiology and Intensive Medicine Specialist

General Hospital Zadar

研究点 (1)

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