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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05342818
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
3.5
Anticipated Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

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

.

Condition or Disease Intervention/Treatment Phase
  • Drug: Neostigmine
  • Drug: Ondansetron 8mg
  • Drug: Metoclopramide Injection
  • Other: Enteral feeding nutrition
  • Other: Sequential Organ Failure Assessment (SOFA) score
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron
Actual Study Start Date :
Apr 15, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

    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

    • 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 M

    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
    will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
    Other Names:
  • primperan 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of Gastric Residual Volume(GRV) [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 [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 Outcome Measures

    1. Blood albumin [4 days]

      blood sampling daily for four days

    2. Complete Blood Count [4 days]

      blood sampling daily for four days

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sharurah Armed Forces Hospital Sharurah Saudi Arabia 000000

    Sponsors and Collaborators

    • Tanta University

    Investigators

    • Principal Investigator: AHMED A SHAMA, MD, Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AHMED ABDELAZIZ SHAMA, LECTURER OF ANESTHESIA AND SURGICAL ICU, Tanta University
    ClinicalTrials.gov Identifier:
    NCT05342818
    Other Study ID Numbers:
    • IRC112/04/22
    First Posted:
    Apr 25, 2022
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by AHMED ABDELAZIZ SHAMA, LECTURER OF ANESTHESIA AND SURGICAL ICU, Tanta University
    gastric residual volume
    neostigmine
    ondansetron
    mechanically ventilated patients
    Additional relevant MeSH terms:
    Gastroparesis
    Ondansetron
    Metoclopramide
    Neostigmine

    Study Results

    No Results Posted as of Apr 25, 2022