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NCT Number: NCT05342818

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

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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Key information

Conditions

Delayed Gastric Emptying Digestive System Diseases Gastrointestinal Diseases Gastroparesis Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sharurah Armed Forces Hospital

Sharurah, 000000, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neostigmine

Drug

will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs

Other names: Neostigmine injection

Ondansetron 8mg

Drug

will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs

Other names: Dansetron injection

Metoclopramide Injection

Drug

will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs

Other names: primperan injection

Enteral feeding nutrition

Other

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 names: Enteral feeding

Sequential Organ Failure Assessment (SOFA) score

Other

SOFA score will be performed on all patients before the beginning of the study

Other names: SOFA score

Primary outcomes

  1. Evaluation of Gastric Residual Volume(GRV)

    Time frame: 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

  2. Volume of the gastric antrum

    Time frame: 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 outcomes

  1. Blood albumin

    Time frame: 4 days

    blood sampling daily for four days

  2. Complete Blood Count

    Time frame: 4 days

    blood sampling daily for four days

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2022
Registry last updated
Oct 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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