伊托必利对司美格鲁肽胃轻瘫的影响
伊托必利能否改善司美格鲁肽诱导的麻醉前胃轻瘫超声表现？随机对照试验
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery.
The investigator will evaluate the effect of Itopride on Semaglutide-induced gastroparesis and residual gastric contents after 8 hours of fasting by gastric ultrasound before anesthesia.
研究概览
详细说明
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride could enhance gastric emptying and hastens surgery.
Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, is gaining popularity for the treatment of type 2 diabetes mellitus (T2DM) and obesity; Semaglutide stimulates insulin excretion and delays gastric emptying.Itopride, a novel prokinetic agent, acts as a dopamine D2 receptor antagonist and an acetylcholine esterase inhibitor. Itopride shows promise in managing gastroparesis symptoms by accelerating gastric emptying, improving gastric tension and sensitivity, and exerting antiemetic effects.
The investigator designed this prospective, randomized, double-blind controlled study to evaluate the effect of Itopride on Semaglutide induced gastroparesis and residual gastric contents after 8-hours fasting by gastric ultrasound before anesthesia.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Cairo、埃及、11591
- faculty of medicine, Ain Shams University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists grade I- III.
- Age: 40-60 years.
- BMI: 20-30 kg/m2.
- Diabetic patients on semaglutide (0.5-1mg) SC weekly.
- Undergoing elective hysterectomy.
Exclusion Criteria:
- Declining to give written informed consent.
- history of upper abdominal surgery or the presence of hiatal hernia.
- Other medications inducing gastroparesis (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, and lithium).
- History of allergy to Itopride.
- History of cardiac arrhythmia or abnormal ECG.
- Neurologic diseases (including Parkinson's disease and multiple sclerosis)
- Hepatic or renal failure.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Itopride HCL
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days |
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days |
|
安慰剂比较：Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days |
Daily placebo tablet TID, 1 hour before meals for 7 days |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Residual gastric contents
大体时间：on day 7
|
Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting . |
on day 7
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
第3天和第5天残留胃内容物。
大体时间：在第3天和第5天
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在第3天和第5天
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麻醉期间呕吐发生率
大体时间：麻醉期间
|
麻醉期间
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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