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临床试验/NCT04403191
NCT04403191已完成不适用

Comparative Study Between Ondansetron, Isopropyl Alcohol Inhalation and Super Hydration in Treatment of Postoperative Emesis After Laparoscopic Appendectomy

King Abdul Aziz Specialist Hospital1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2019年3月10日最近更新:
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
240
试验地点
1
主要终点
numbers of vomiting attacks

研究概览

简要总结

To compare and evaluate the antiemetic effect and the safety of ondansetron, inhalational isopropyl alcohol and super hydration on adult patients after laparoscopic appendectomy.

详细描述

This prospective double-blind study done on 240 patients admitted to surgical I.C.U after laparoscopic appendectomy. Those who had preoperative Koivuranta vomiting score of more than 3 enrolled in our study. Every group contains 80 patients. Patients of group A received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group B received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours. The last group C received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours. The duration of the study was 24 hours post-operatively. As PONV is self-limited within 24 hours.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • postoperative nausea and vomiting

排除标准

  • systemic disease as diabetes or hypertension local gastric diseases

研究组 & 干预措施

Group B

received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours

干预措施: laparoscopic appendectomy (Procedure)

Group A

received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours

干预措施: Ondansetron (Drug)

Group A

received ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours

干预措施: laparoscopic appendectomy (Procedure)

Group B

received isopropyl alcohol 70% inhalation every 15 min for 4 times then repeated after 6 hours

干预措施: isopropyl alcohol 70% inhalation (Drug)

Group C

received intravenous normal saline at rate of 20 ml/kg over 30 minute and repeated by the same dose after 6 hours.

干预措施: laparoscopic appendectomy (Procedure)

结局指标

主要结局

numbers of vomiting attacks

时间窗: for one day

numbers of vomiting attacks recorded every 15 minutes for one day

次要结局

未报告次要终点

研究者

发起方
King Abdul Aziz Specialist Hospital
申办方类型
Network
责任方
Sponsor

研究点 (1)

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