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临床试验/CTRI/2026/03/106726
CTRI/2026/03/106726尚未招募Phase 3 4

To Compare the Efficacy and Safety of Intravenous Amisulpride Against Dexamethasone in Post-Surgical Patients to Prevent Post-Operative Nausea and Vomiting (PONV): A Randomized, Controlled, Prospective Study

Reena Kankotiya1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
120
试验地点
1

研究概览

简要总结

Postoperative nausea and vomiting  is a common and distressing complication following surgery and anesthesia, leading to patient discomfort, delayed recovery, and increased healthcare costs. Various pharmacological agents are used for its prevention, among which dexamethasone is widely employed. Amisulpride, a selective dopamine  receptor antagonist, has recently emerged as a potential alternative for Post operative nausea and vomiting prophylaxis.

This prospective, randomized, controlled study aims to compare the efficacy and safety of intravenous amisulpride with intravenous dexamethasone in preventing post operative nausea and vomiting in post-surgical patients. Eligible patients undergoing surgery under general anesthesia will be randomly allocated into two groups to receive either intravenous amisulpride or dexamethasone intraoperatively. The primary outcome will be the incidence of postoperative nausea and vomiting within the first twenty four hours after surgery. Secondary outcomes will include severity of nausea, need for rescue antiemetics, and incidence of adverse effects.

The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of intravenous amisulpride versus dexamethasone, thereby aiding anesthesiologists in selecting optimal prophylactic therapy for Post operative nausea and vomiting

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

  • : Surgery to last at least 1 hour :Overnight stay :General anaesthesia :ASA I&II :At least one of the following Apfel et al’s risk factors for PONV: Female sex Non-smoking status A prior history of PONV or motion sickness Being expected to receive postoperative opioid analgesia.

排除标准

  • 未提供

研究者

发起方
Reena Kankotiya
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Reena Kankotiya

Sumandeep vidhyapeeth

研究点 (1)

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