Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Evaluation of Gastric Residual Volume(GRV)
研究概览
简要总结
One big problem in mechanically ventilated ICU patients is delayed gastric emptying. Delayed gastric emptying in these patients, causes intolerance and high gastric residual volume (GRV) that can lead to abdominal distention, vomiting, increased aspiration risk and consequently increased the length of hospital stay.
In this study, investigators will evaluate Neostigmine's effect in reducing GRV in mechanically ventilated patients and compare its effect with metoclopramide and Ondansetron
.
详细描述
It has been shown that delayed gastric emptying and high GRV in critically ill patients are associated with increased mortality in these patients. Different kinds of drugs including metoclopramide, erythromycin and cisapride are used, but none of them had conclusive evidence of better effects on each other. Moreover, complications such as dysrhythmia and extrapyramidal side effects limit the use of these drugs.
Another drug that can be used to increase gastric emptying in critically ill patients is neostigmine. Although several studies have evaluated the efficacy of neostigmine on postoperative ileus, very few studies have evaluated the effect of this drug on GRV in ICU patients.
The aim of the current study will be to compare the effects of Neostigmine on gastric residual volume in mechanically ventilated patients in the intensive care unit. A comparative controlled study by Ondansetron.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mechanically ventilated ICU patients
- •With nasogastric tube feeding
- •Gastric Residual Volume >120 mL (3hours after the last gavage)
排除标准
- •History of diabetes
- •Heart block
- •Bradycardia (heart rate <60/min)
- •Systolic blood pressure less than 90 mm Hg
- •Renal insufficiency
- •Using any prokinetic agents such as erythromycin or cisapride within 8 hours before study initiation
- •Recent surgery (10 days or less) on the stomach or digestive system
- •pregnancy and lactation
- •Occurrence of extrapyramidal side effects
- •Gastrointestinal (GI) bleeding
研究组 & 干预措施
Group N
patients will receive an intravenous infusion of neostigmine in a dose of 2.5 mg in 100 ml of normal saline within 20 minutes once daily
干预措施: Neostigmine (Drug)
Group N
patients will receive an intravenous infusion of neostigmine in a dose of 2.5 mg in 100 ml of normal saline within 20 minutes once daily
干预措施: Enteral feeding nutrition (Other)
Group N
patients will receive an intravenous infusion of neostigmine in a dose of 2.5 mg in 100 ml of normal saline within 20 minutes once daily
干预措施: Sequential Organ Failure Assessment (SOFA) score (Other)
Group O
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
干预措施: Ondansetron 8mg (Drug)
Group O
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
干预措施: Enteral feeding nutrition (Other)
Group O
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
干预措施: Sequential Organ Failure Assessment (SOFA) score (Other)
Group M
patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion
干预措施: Metoclopramide Injection (Drug)
Group M
patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion
干预措施: Enteral feeding nutrition (Other)
Group M
patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion
干预措施: Sequential Organ Failure Assessment (SOFA) score (Other)
结局指标
主要结局
Evaluation of Gastric Residual Volume(GRV)
时间窗: 12 hours
Patients' GRVs will be evaluated before the intervention, then 3, 6, 9 and 12 hours after the intervention using a gavage syringe by an expert nurse who had been unaware of the study groups
Volume of the gastric antrum
时间窗: 4 days
After five half-lives of drugs, the volume of the gastric antrum of the patients will be measured by ultrasonography 3 hours after gavage.
次要结局
- Blood albumin(4 days)
- Complete Blood Count(4 days)
研究者
AHMED ABDELAZIZ SHAMA
LECTURER OF ANESTHESIA AND SURGICAL ICU
Tanta University