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临床试验/NCT02809950
NCT02809950Unknown4 期

Effects of Preoperative Oral Carbohydrates Loading in Patients at High Risk of Postoperative Nausea and Vomiting Undergoing Spinal Surgery

Yonsei University2 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
288
试验地点
2
主要终点
incidence of nausea and vomiting

研究概览

简要总结

Many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with antiemetic agents. Dehydration caused by fasting prior to surgery is associated with the development of PONV. The aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of PONV undergoing spinal 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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • female patient between 20 and 65 of age with ASA physical status Ⅰ-Ⅱ
  • patient scheduled for elective spine surgery
  • no smoking history

排除标准

  • hepatorenal disease
  • BMI > 35 kg/m2
  • gastrointestinal disease
  • vomiting within 24h
  • administration of antiemetics or opioids within 24 h prior to surgery
  • problem with communication

研究组 & 干预措施

oral carbohydrate beverage group

Experimental

干预措施: oral carbohydrate beverage (Other)

control group

Placebo Comparator

干预措施: control group (Other)

结局指标

主要结局

incidence of nausea and vomiting

时间窗: 48 hours

次要结局

  • severity of nausea(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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