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

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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Study Overview

• Status: Completed
• Conditions: Delayed Gastric Emptying
• Intervention / Treatment: Drug: Neostigmine; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score; Drug: Ondansetron 8mg; Drug: Metoclopramide Injection

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• Saudi Arabia
  • Sharurah, Saudi Arabia, 000000
    • Sharurah Armed Forces Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group N; 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; will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; Other Names: Neostigmine injection; 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 Names: Enteral feeding; Other: Sequential Organ Failure Assessment (SOFA) score; SOFA score will be performed on all patients before the beginning of the study; Other Names: SOFA score
Experimental: Group O; patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes	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 Names: Enteral feeding; Other: Sequential Organ Failure Assessment (SOFA) score; SOFA score will be performed on all patients before the beginning of the study; Other Names: SOFA score; Drug: Ondansetron 8mg; will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; Other Names: Dansetron injection
Experimental: Group M; patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion	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 Names: Enteral feeding; Other: Sequential Organ Failure Assessment (SOFA) score; SOFA score will be performed on all patients before the beginning of the study; Other Names: SOFA score; Drug: Metoclopramide Injection; will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs; Other Names: primperan injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): October 17, 2022

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: April 17, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 18, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ondansetron; neostigmine; gastric residual volume; mechanically ventilated patients
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Anti-Anxiety Agents; Antipruritics; Cholinesterase Inhibitors; Parasympathomimetics; Ondansetron; Neostigmine; Metoclopramide
• Other Study ID Numbers: IRC112/04/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No