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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Delayed Gastric Emptying

Treatments: Other: Sequential Organ Failure Assessment (SOFA) score; Drug: Neostigmine; Drug: Ondansetron 8mg; Drug: Metoclopramide Injection; Other: Enteral feeding nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT05342818

IRC112/04/22

Details and patient eligibility

About

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

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Full 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.

Enrollment: 90 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Group N

Experimental group

Description:

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

Treatment:

Other: Enteral feeding nutrition

Drug: Neostigmine

Other: Sequential Organ Failure Assessment (SOFA) score

Group O

Experimental group

Description:

patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes

Treatment:

Other: Enteral feeding nutrition

Drug: Ondansetron 8mg

Other: Sequential Organ Failure Assessment (SOFA) score

Group M

Experimental group

Description:

patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion

Treatment:

Other: Enteral feeding nutrition

Drug: Metoclopramide Injection

Other: Sequential Organ Failure Assessment (SOFA) score