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临床试验/NCT01478165
NCT01478165已完成不适用

Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)

Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011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
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Incidence of postoperative nausea and vomiting

研究概览

简要总结

A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV).

Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.

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)

入排标准

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

入选标准

  • ASA Physical Status 1 or 2
  • Elective gynaecological laparoscopic surgery of ≥ 1h duration

排除标准

  • Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
  • Vomiting or retching in the 24 h preceding surgery
  • Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
  • Ongoing vomiting from gastrointestinal disease

研究组 & 干预措施

Tiva group (Group T)

Placebo Comparator

干预措施: Total intravenous anesthesia (Drug)

TIVA plus palonosetron group (Group T+P)

Active Comparator

干预措施: Total intravenous anesthesia plus palonosetron (Drug)

结局指标

主要结局

Incidence of postoperative nausea and vomiting

时间窗: For 24 hours after surgery

次要结局

  • Severity of nausea(For 24 hours after surgery)

研究者

发起方
Incheon St.Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Soo Kyoung Park

Clnical professor

Incheon St.Mary's Hospital

研究点 (1)

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