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临床试验/CTRI/2025/09/095445
CTRI/2025/09/095445尚未招募不适用

Amisulpride over Ondansetron for Postoperative Nausea and Vomiting prophylaxis: A double blind Randomized control study

Dr Aman Mathur1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年10月9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
66
试验地点
1
主要终点
To compare antiemetic action of Amisulpride with Ondansetron.

研究概览

简要总结

Nausea and vomiting are very common after any major surgical procedure. Therefore, antiemetic prophylaxis is frequently used to reduce this complication and promote patient comfort. Amisulpride is being used as a treatment for post operative nausea vomiting but its use as a prophylaxis for the same is relatively less studied. The primary objective of this study is to compare antiemetic action of 5mg IV Amisulpride over 4mg IV Ondansetron as a prophylaxis given to adults undergoing General Anaesthesia for laparoscopic cholecystectomy. In this study two randomized groups “A” and “O” are allocated where Group “A’’ receives 5mg IV Amisulpride and Group “O” receives 4mg IV Ondansetron. This Prospective Randomised Double Blind Control Study will be conducted in the Department of Anaesthesia and Critical care, Central Hospital NF Railways over a period of 18 months on patients of ASA Physical status I and II aged between 25-55 years. Presence of complain of nausea and vomiting, retching, need for rescue antiemetic drug is assessed at 3h,6h,12h,24h post operatively and PONV impact scale score calculated over 24 hours. It is hypothesized that Amisulpride is better for prophylaxis of PONV as compared to Ondansetron.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to ASA 1 and ASA 2 category
  • Patients willing to give written informed consent
  • Patients with APFEL score 2 or more than 2.

排除标准

  • Patient who received any additional drug or intervention along with the standardized anesthesia procedure during surgery.
  • (Patients whose anesthesia procedure is deviated from routine institutional protocol.)
  • Patients with known allergy to study drugs.
  • Pregnant and lactating mothers.
  • Known psychiatric disorder on antipsychotic drugs.

结局指标

主要结局

To compare antiemetic action of Amisulpride with Ondansetron.

时间窗: 3,6,12,24 hours post operatively.

次要结局

  • To assess the patient post operatively for any side effects.(3,6,12,24 hours post operatively)

研究者

发起方
Dr Aman Mathur
申办方类型
Other [Dr Aman Mathur]
责任方
Principal Investigator
主要研究者

AMAN MATHUR

Central Hospital NFR

研究点 (1)

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