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临床试验/NCT05396716
NCT05396716Unknown不适用

Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery

Zhihong LU0 个研究点目标入组 158 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
158
主要终点
incidence of nausea and vomiting by 24 hours after surgery

研究概览

简要总结

Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The stimulator is put in an opaque box

入排标准

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

入选标准

  • age ≥18 years
  • scheduled for elective liver surgery under general anesthesia

排除标准

  • body mass index less than 18 kg/m2 or higher than 30 kg/m2
  • American Society of Anesthesiologists status higher than Ⅲ
  • patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
  • suspected or existed abuse of drug or alcohol
  • pregnant or breeding women
  • history of neurological or psychiatric disease

结局指标

主要结局

incidence of nausea and vomiting by 24 hours after surgery

时间窗: from end of surgery to 24 hours after surgery, in a total of 24 hours

次要结局

  • Quality of recovery score at 24 hours after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)
  • score of nausea and vomiting by 48 hours after surgery(from end of surgery to 48 hours after surgery, in a total of 48 hours)
  • score of nausea and vomiting in PACU(post-anesthesia care unit)(from end of surgery to discharge from PACU, in an average of 30 minutes)
  • Quality of recovery score at 48 hours after surgery(from end of surgery to 48 hours after surgery, in a total of 48 hours)
  • incidence of nausea and vomiting in PACU (post-anesthesia care unit)(from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes)
  • incidence of nausea and vomiting by 48 hours after surgery(from end of surgery to 48 hours after surgery, in a total of 48 hours)
  • score of nausea and vomiting by 24 hours after surgery(from end of surgery to 24 hours after surgery, in a total of 24 hours)
  • postoperative in-hospital stay(from end of surgery to discharge from hospital, in an average of 7 days)
  • death by 6 months after surgery(from end of surgery to 6 months after surgery, in a total of 6 months)

研究者

发起方
Zhihong LU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhihong LU

Associate professor

Air Force Military Medical University, China

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