Delayed Gastric Emptying
Conditions
Keywords
gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients
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.
Interventions
DRUGNeostigmine
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
DRUGOndansetron 8mg
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
OTHEREnteral feeding nutrition
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
OTHERSequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Blood albumin | 4 days | blood sampling daily for four days |
| Complete Blood Count | 4 days | blood sampling daily for four days |
Countries
Saudi Arabia
Outcome results
None listed