CTRI/2024/03/063683已完成不适用
Effectiveness of preoperative Olanzapine versus Placebo, as an add on drug, on the incidence of postoperative nausea and vomiting in laparoscopic gynecological surgeries: a stratified randomised control trial
Dr Prasanta Kumar Das1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年3月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To compare the incidence of PONV in first 24 hours after surgery between two groups
研究概览
简要总结
Postoperative nausea and vomiting (PONV) is the most distressing event after laparoscopic gynecological surgeries. There have been studies showing the incidence is still nearly 40% even after using dual prophylactic measures. Olanzapine has been effective in reducing PONV in chemotherapy induced nausea and vomiting. In this study we hypothesize that administering preoperative oral Olanzapine in addition to intraoperative ondansetron and dexamethasone would further reduce the incidence of PONV.
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
- Female
入选标准
- •Gynecological patients undergoing laparoscopic surgeries ASA 1 and 2.
排除标准
- •no consent, allergic to study drugs, renal and hepatic failure, on antiemetic and antipsychotic medications, prolonged qt interval, history of obstructive sleep apnea.
结局指标
主要结局
To compare the incidence of PONV in first 24 hours after surgery between two groups
时间窗: To compare the incidence of PONV in first 24 hours after surgery between two groups
次要结局
- severity of nausea and vomting by 4- point severity scale(over 24 hours)
- requirement of rescue antiemetic (inj.Metoclopramide 10mg IV)(12 hours)
- Quality of recovery(QoR - 15)(over 24 hours)
- Side effects of Olanzapine(over 24 hours)
研究者
Dr Nirmala Phobba
AIIMS BHUBANESWAR
研究点 (1)
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