临床试验/CTRI/2024/09/073589

CTRI/2024/09/073589尚未招募3 期

Comparison Of Intravenous Amisulpride With Intravenous Ondansetron In The Prophylaxis Of Postoperative Nausea And Vomiting In Patients Undergoing Craniotomy For Supratentorial Tumour Surgery: A Randomized Controlled Trial.

Academic session Sree Chitra Thirunal Institute of Science and Technology1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年10月2日最近更新: 2024年8月24日

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 100
试验地点: 1
主要终点: To determine the effectiveness of amisulpride vs ondansetron in prevention of post operative nausea and vomiting during the first 24 hours in patients undergoing craniotomy for supratentorial tumor.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

We plan to conduct a prospective randomised controlled trial to compare intravenous amisulpride with intravenous ondansetron in the prevention of postoperative nausea and vomiting in patients undergoing elective craniotomy for supratentorial tumour decompression.

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: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Adult patients undergoing supratentorial craniotomy for tumour.

排除标准

•Patient refusal 2)Patients with history of drug or alcohol abuse 3)History of nausea or vomiting 4)Pregnant or lactating women 5)Chemotherapy or radiation therapy during the previous 1month 6)Planned for postoperative ventilation.

结局指标

主要结局

To determine the effectiveness of amisulpride vs ondansetron in prevention of post operative nausea and vomiting during the first 24 hours in patients undergoing craniotomy for supratentorial tumor.

时间窗: 1 year for the recruitment | 1 month for data analysis

次要结局

To compare the severity of nausea, use of rescue medications, postoperative pain and analgesic requirement, and incidences of adverse events in the first 24 hours postoperatively, in patients receiving amisulpride and ondansetron who are undergoing craniotomy for supratentorial tumor.(1 year for the recruitment)

研究者

发起方

Academic session Sree Chitra Thirunal Institute of Science and Technology

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Ajay Prasad Hirshi

Sree Chitra Thirunal Institute of Medical Sciences and Technology,

研究点 (1)

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