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临床试验/CTRI/2024/11/077170
CTRI/2024/11/077170尚未招募不适用

Comparison of Amisulpride vs Ondansetron in the prophylaxis of Post Operative Nausea and Vomiting in abdominal surgeries: a randomized controlled study.

Department Of Anesthesiology Institute of Medical Sciences Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年12月11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
180
试验地点
1
主要终点
1. association of redcution in PONV With amisulpride in comparison to ondansetron

研究概览

简要总结

Presently dopamine (D2), serotonin (5-HT3), and histamine (H1) antagonists are widely used prophylactic agents, as is the corticosteroid dexamethasone, but the incidence of postoperative nausea and vomiting (PONV) is still appreciable. Safety concerns as QT interval prolongation has led to nearly phasing out of use of D2-antagonist Droperidol, a potent and most favoured formulation. With minimal studies and randomized studies to back up the efficacy of existing modalities viz 5HT-antagonist, promethazine, metoclopramide and dimenhydrinate for management of postoperative nausea and vomiting, need for evaluation, study and incorporation into formulary for management was always persisting.[ 3]

Amisulpride is an anti-psychotic agent, used routinely are a potent but atypical D2-antagonist with minimal adverse profile mainly QT interval prolongation, as compared to ondansetron extrapyramidal signs and symptoms, which had plagued out other members of same class. In addition to D2 antagonism this

drug exhibits potent antagonist action against D3 receptors, implicated in the emetic response. In pre-clinical studies and multiple randomized controlled multicentre studies, the effectiveness and safety of low dose intra venous the purpose of this study is To study effects on post operative nausea and vomiting in patients receiving amisulpride 5mg  and compare it with patients receiving 4mg of ondansetron using apfel score and koivuranta nausea and vomiting total score

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

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

入选标准

  • ASA I or II physical status
  • patient’s consent 4.Patients with three or more risk factors for nausea and vomiting.

排除标准

  • Pregnancy lactation renal impairment History of allergic reaction to the drugs mentioned in study.
  • Refusal to take part in the study.
  • Patients with dysrhythmia.

结局指标

主要结局

1. association of redcution in PONV With amisulpride in comparison to ondansetron

时间窗: 1.KOIVURANTA SCALE | 2. APFEL SCORE

次要结局

  • 1.to asses post op nausea vomiting at(1. 2hrs,6hrs,24hrs post operatively)

研究者

发起方
Department Of Anesthesiology Institute of Medical Sciences Banaras Hindu University
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Harshita Sinha

Institute of Medical Sciences Banaras Hindu University

研究点 (1)

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