Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Residual gastric contents
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists grade I- III.
- •Age: 40-60 years.
- •BMI: 20-30 kg/m
- •Diabetic patients on semaglutide (0.5-1mg) SC weekly.
- •Undergoing elective hysterectomy.
排除标准
- •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.
研究组 & 干预措施
Itopride HCL
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
干预措施: Itopride HCI 50 mg (Drug)
Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Residual gastric contents
时间窗: 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 .
次要结局
- Incidence of vomiting during anesthesia(during anesthesia)
- Residual gastric contents on day 3 and day 5.(on day 3 and day 5)
研究者
Tamer Samir Abdelsalam
Assistant professor of anesthesia, Intensive care and Pain medicine
Ain Shams University