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临床试验/NCT05014737
NCT05014737Unknown不适用

External Validation of Two Models to Predict Postoperative Nausea and Vomiting (PONV) in Patients With Liver Cancer in Chinese Hospital Setting

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
214
试验地点
1
主要终点
postoperative nausea and vomiting

研究概览

简要总结

Postoperative nausea and vomiting (PONV) is a common complication among surgical patients. The incidence ranging from 20% to 50% depends on different population studied. Clinical practice guidelines recommend routine PONV screening before surgery using the Apfel simplified risk score OR Koivuranta score. However, these two scores haven't been translated into Chinese version and tested for psychometric qualities. Therefore, this study aim to externally validate two PONV prediction models in the Chinese hospital setting for PONV assessment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • patients receiving hepatobiliary surgery

排除标准

  • patients receiving chemothreapy;patients with cognitive disorders; patients unwilling to participate.

结局指标

主要结局

postoperative nausea and vomiting

时间窗: 24 hours after surgery

Postoperative nausea will be assessed at 24 hours after surgery on an 11-point numeric scale (0 -10) by a trained nurse. Patients will be asked to respond to the question, "Have you felt nauseated since your discharge from the postanesthetic care unit and if so, what would be the average level of nausea you have felt until now on a 0 to 10 scale?". Patients will be considered nauseated if postoperative nausea is reported to be greater than zero on the 11-point scale with the question. For the same intervals the number of episodes of postoperative vomiting will be recorded. Again, patients will be considered to have vomited if postoperative vomiting occurs at least once within 24 hours. Patients who have either postoperative nausea or postoperative vomiting in 24h will be considered to have PONV.

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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