CTRI/2024/10/075539尚未招募Phase 3 4
Comparison of Amisulpride versus Dexamethasone for prevention of PONV after laparoscopy assisted vaginal hysterectomy
Dr Aditya Deepak1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2024年12月2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
- 128
- 试验地点
- 1
- 主要终点
- Postoperative nausea or vomiting
研究概览
简要总结
This study is for DNB Anaesthesia Thesis submission. It compares our current practice of giving one dose of Dexamethasone antiemetic for LAVH surgery with the newer antiemetic Amisulpride, which is already an established antiemetic in general use for chemotherapy induced nausea and vomiting. We will monitor for its efficacy in the perioperative setting and give rescue antiemetics if needed. We will also monitor for any side effects and treat them appropriately.
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 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Elective Laparoscopy Assisted Vaginal Hyseterectomy procedures of less than 4 hours duration ASA 1 to 3 Weight 40 to 90 kg.
排除标准
- •Allergy to dexamethasone or amisulpride History of motion sickness or previous PONV Having nausea, vomiting or antiemetic medication in the 24 hours before surgery.
结局指标
主要结局
Postoperative nausea or vomiting
时间窗: From extubation to next morning 9 am
次要结局
- Use of rescue antiemetic(From extubation to next morning 9 am)
研究者
Aditya Deepak
Kovai Medical Center and Hospital, Coimbatore
研究点 (1)
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