Effects of a Single Dose Dexmedetomidine on Postoperative Nausea and Vomiting (PONV) and Quality of Recovery 40 (QoR 40) in Breast Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Quality of Recovery 40 (QoR-40)
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is common following beast surgery. Dexmedetomidine was reported to a reduced PONV due to opioid-sparing effect. It is not clear if dexmedetomidine itself is useful on reducing PONV. The hypothesis of present study: intraoperative application of single dose dexmedetomidine (0.5 mcg/kg) is is effective than placebo for reducing of PONV and improve postoperative quality of recovery score within 48 postoperative hours.
详细描述
This study was approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System. After written informed consent was obtained from all patients, aged 20-75 years with ASA physical status class I-II who were scheduled breast cancer surgery under general anaesthesia were enrolled in this study All the patients were randomly assigned to receive dexmedetomidine or placebo during surgery. The primary outcome was quality of recovery determined by QOR-40 in the first 24h after surgery.The secondary outcome measure was PONV assessed by visual analogue scale every 6 hours within 48 postoperative hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I, II
- •aged 20-70 years
- •Undergoing breast cancer surgery
排除标准
- •Bradycardia
- •QT prolongation
研究组 & 干预措施
Group D
A single dose dexmedetomidine 0.5 mcg/kg iv. 30 min before end of the surgery
干预措施: Dexmedetomidine (Drug)
Group P
Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Quality of Recovery 40 (QoR-40)
时间窗: 24 postoperative hours
quality of recovery was determined by QOR-40 questionnaire. (all same as Dexmedetomidine group and Placebo group)
次要结局
- Change from preoperative baseline in PONV within 48 postoperative hours(every 6 hours within 48 postoperative hours)