Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
NCT ID: NCT05342818
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2022-04-15
2022-10-17
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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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
Neostigmine
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
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
Sequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study
Group O
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
Ondansetron 8mg
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
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
Sequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study
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
Metoclopramide Injection
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
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
Sequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study
Interventions
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Neostigmine
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Ondansetron 8mg
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Metoclopramide Injection
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
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
Sequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With nasogastric tube feeding
* Gastric Residual Volume \>120 mL (3hours after the last gavage)
Exclusion Criteria
* 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
25 Years
75 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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AHMED ABDELAZIZ SHAMA
LECTURER OF ANESTHESIA AND SURGICAL ICU
Principal Investigators
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AHMED A SHAMA, MD
Role: PRINCIPAL_INVESTIGATOR
Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
Locations
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Sharurah Armed Forces Hospital
Sharurah, , Saudi Arabia
Countries
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Other Identifiers
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IRC112/04/22
Identifier Type: -
Identifier Source: org_study_id
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