Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
- Conditions
- Delayed Gastric Emptying
- Interventions
- Other: Enteral feeding nutritionOther: Sequential Organ Failure Assessment (SOFA) score
- Registration Number
- NCT05342818
- Lead Sponsor
- Tanta University
- Brief Summary
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
.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Mechanically ventilated ICU patients
- With nasogastric tube feeding
- Gastric Residual Volume >120 mL (3hours after the last gavage)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group M Metoclopramide Injection patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion Group N Enteral feeding nutrition 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 Group N Sequential Organ Failure Assessment (SOFA) score 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 Group O Ondansetron 8mg patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes Group O Enteral feeding nutrition patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes Group O Sequential Organ Failure Assessment (SOFA) score patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes Group M Enteral feeding nutrition patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion Group M Sequential Organ Failure Assessment (SOFA) score patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion Group N Neostigmine 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
- Primary Outcome Measures
Name Time Method Evaluation of Gastric Residual Volume(GRV) 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 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.
- Secondary Outcome Measures
Name Time Method Blood albumin 4 days blood sampling daily for four days
Complete Blood Count 4 days blood sampling daily for four days
Trial Locations
- Locations (1)
Sharurah Armed Forces Hospital
🇸🇦Sharurah, Saudi Arabia