Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Estimated Gastric volume
研究概览
简要总结
In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Non-laboring pregnant women ≥36 weeks gestational age
- •Parturient scheduled for elective caesarian delivery.
- •Singleton pregnancy
- •Age greater than 18 years
- •Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food)
- •Exclusion criteria:
- •Refusal of the patient
- •Deviation from fasting times
- •Patients with empty stomach
- •Emergency operation
- •Body mass index (BMI) greater than 40 kg/m2
- •American Society of Anesthesiologists (ASA) physical status class III, IV.
- •Gestational diabetes mellitus
- •Multiple gestations
- •Patients with polyhydramnios liquor.
- •Preeclampsia patients
- •Chronic kidney disease patients
- •Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis).
- •Patients with gastrointestinal diseases such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries.
- •Patients on antidepressants and monoamine oxidase inhibitors
- •Use of other medications known to affect gastric motility or secretions.
- •Allergy to macrolide or metoclopramide
排除标准
- 未提供
研究组 & 干预措施
Group (C)
will be receive flavored water in total volume 15 ml
干预措施: naturally flavored water (Dietary Supplement)
Group (M)
will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml
干预措施: metoclopramide (10mg) (Drug)
Group (E)
will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml
干预措施: Erythromycin (400mg) (Drug)
结局指标
主要结局
Estimated Gastric volume
时间窗: UP TO 6 HOURE
(ml/kg) after a six-hour fast using Roukhomovsky's equation after administration of the study drug.
次要结局
- quantitative gastric contents(up to 24 hours)
- low-risk stomach six hours after drug administration(up to 6 hours)
- Perlas grading system(UP TO 24 HOURE)
- Evaluation of the risk of aspiration(UP TO 24 HOURE)
研究者
Amr Samir Wahdan
Lecturer of Anesthesia, Pain management and Surgical ICU
Cairo University