Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron

Conditions
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Delayed Gastric Emptying

Intervention / Treatment
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* Drug: Neostigmine
* Drug: Ondansetron 8mg
* Drug: Metoclopramide Injection
* Other: Enteral feeding nutrition
* Other: Sequential Organ Failure Assessment (SOFA) score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mechanically ventilated ICU patients With nasogastric tube feeding Gastric Residual Volume >120 mL (3hours after the last gavage) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group N<br>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 | Drug: Neostigmine<br>* will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs<br>* Other names: Neostigmine injection;Other: Enteral feeding nutrition<br>* The type and rate of enteral feeding nutrition will be the same for all patients (180ml/3h). All patients have a 30-degree head-up position<br>* Other names: Enteral feeding;Other: Sequential Organ Failure Assessment (SOFA) score<br>* SOFA score will be performed on all patients before the beginning of the study<br>* Other names: SOFA score;|
| Experimental: Group O<br>patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes | Drug: Ondansetron 8mg<br>* will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs<br>* Other names: Dansetron injection;Other: Enteral feeding nutrition<br>* The type and rate of enteral feeding nutrition will be the same for all patients (180ml/3h). All patients have a 30-degree head-up position<br>* Other names: Enteral feeding;Other: Sequential Organ Failure Assessment (SOFA) score<br>* SOFA score will be performed on all patients before the beginning of the study<br>* Other names: SOFA score;|
| Experimental: Group M<br>patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion | Drug: Metoclopramide Injection<br>* will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs<br>* Other names: primperan injection;Other: Enteral feeding nutrition<br>* The type and rate of enteral feeding nutrition will be the same for all patients (180ml/3h). All patients have a 30-degree head-up position<br>* Other names: Enteral feeding;Other: Sequential Organ Failure Assessment (SOFA) score<br>* SOFA score will be performed on all patients before the beginning of the study<br>* Other names: SOFA score;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Gastric Residual Volume(GRV) | 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 | 12 hours | 
| Volume of the gastric antrum | After five half-lives of drugs, the volume of the gastric antrum of the patients will be measured by ultrasonography 3 hours after gavage. | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood albumin | blood sampling daily for four days | 4 days | 
| Complete Blood Count | blood sampling daily for four days | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients