NCT05342818

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Delayed Gastric Emptying

Interventions

Type	Name	Description
DRUG	Neostigmine	will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
DRUG	Ondansetron 8mg	will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
DRUG	Metoclopramide Injection	will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
OTHER	Enteral 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
OTHER	Sequential Organ Failure Assessment (SOFA) score	SOFA score will be performed on all patients before the beginning of the study

Timeline

• Start date: 2022-04-15
• Primary completion: 2022-07-30
• Completion: 2022-10-17
• First posted: 2022-04-25
• Last updated: 2022-10-20

Locations

1 site across 1 country: Saudi Arabia