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临床试验/CTRI/2024/03/064564
CTRI/2024/03/064564尚未招募不适用

A comparative study of Palonosetron And Granisetron for prevention of postoperative nausea and vomiting in patients undergoing laparoscopic surgeries.

Dr. Priyanka Prasannan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Postoperative nausea and vomiting

研究概览

简要总结

Post operative nausea and vomiting along with patient dissatisfaction has many other adverse effects such as delayed recovery and extended hospital stay. The incidence of post operative nausea and vomiting was observed 30% in laparoscopic surgeries is as high as  as 70-80%. Granisetron and palonosetron are selective 5HT3 receptor antagonists that play an important role in the prophylaxis of PONV as they are more efficacious  and have lesser side effects when compared to other antiemetics. Hence the present double blind study to compare the efficacy of palanosetron and granisetron in PONV in laparoscopic surgeries.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA Physical status I and II.
  • Elective Laparoscopic surgeries requiring general anaesthesia with endotracheal intubation and controlled ventilation.
  • Patients willing to give informed consent.

排除标准

  • ASA Physical status III and IV.
  • Patients with emetic episodes in the 24 hours prior to surgery.
  • Pregnancy or lactating mothers.
  • Emergency surgeries.
  • Patients with history of smoking or PONV or motion sickness.
  • Patients on medications that cause QT.
  • Prolongation.

结局指标

主要结局

Postoperative nausea and vomiting

时间窗: 0-2 hours, 2-6 hours, 6-24 hours, 24-48 hours

次要结局

  • Post-operative vitals(30mins,60mins,90 mins,120 mins,3rd hour,4th hour,5th hour,6th hour,8th hour,12th hour,16th hour,20th hour,24th hour,28th hour,32nd hour,36th hour,40th hour,44th hour,48th hour)

研究者

发起方
Dr. Priyanka Prasannan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Priyanka Prasannan

BGS Global Institute of Medical Sciences

研究点 (1)

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