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

NCT05342818 | Completed Phase 2

• 1 other identifier: IRC112/04/22
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 .

Conditions

Delayed Gastric Emptying

Keywords

gastric residual volume; neostigmine; ondansetron; mechanically ventilated patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Blood albumin

  4 days

• Complete Blood Count

  4 days

Study Arms (3)

Group N

EXPERIMENTAL

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; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score

Group O

EXPERIMENTAL

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

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

Group M

EXPERIMENTAL

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

Drug: Metoclopramide Injection; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score

Interventions

Neostigmine DRUG

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

Also known as: Neostigmine injection

Group N

Ondansetron 8mg DRUG

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

Also known as: Dansetron injection

Group O

Metoclopramide Injection DRUG

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

Also known as: primperan injection

Group M

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

Also known as: Enteral feeding

Group M; Group N; Group O

Sequential Organ Failure Assessment (SOFA) score OTHER

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

Also known as: SOFA score

Group M; Group N; Group O

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mechanically ventilated ICU patients
• With nasogastric tube feeding
• Gastric Residual Volume \>120 mL (3hours after the last gavage)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Sharurah Armed Forces Hospital

Sharurah, 000000, Saudi Arabia

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

Neostigmine; Ondansetron; Metoclopramide; Enteral Nutrition

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• AHMED A SHAMA, MD

  Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER OF ANESTHESIA AND SURGICAL ICU

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 25, 2022
• Study Start: April 15, 2022
• Primary Completion: July 30, 2022
• Study Completion: October 17, 2022
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)