Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
Primary Purpose
Delayed Gastric Emptying
Status
Completed
Phase
Phase 2
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Neostigmine
Ondansetron 8mg
Metoclopramide Injection
Enteral feeding nutrition
Sequential Organ Failure Assessment (SOFA) score
Sponsored by
About this trial
This is an interventional prevention trial for Delayed Gastric Emptying focused on measuring gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients
Eligibility Criteria
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
Sites / Locations
- Sharurah Armed Forces Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Group N
Group O
Group M
Arm Description
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
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Blood albumin
blood sampling daily for four days
Complete Blood Count
blood sampling daily for four days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05342818
Brief Title
Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
Official Title
Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
October 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
No
5. 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
.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Gastric Emptying
Keywords
gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group N
Arm Type
Experimental
Arm Description
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
Arm Title
Group O
Arm Type
Experimental
Arm Description
patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes
Arm Title
Group M
Arm Type
Experimental
Arm Description
patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Other Intervention Name(s)
Neostigmine injection
Intervention Description
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Intervention Type
Drug
Intervention Name(s)
Ondansetron 8mg
Other Intervention Name(s)
Dansetron injection
Intervention Description
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Intervention Type
Drug
Intervention Name(s)
Metoclopramide Injection
Other Intervention Name(s)
primperan injection
Intervention Description
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Intervention Type
Other
Intervention Name(s)
Enteral feeding nutrition
Other Intervention Name(s)
Enteral feeding
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sequential Organ Failure Assessment (SOFA) score
Other Intervention Name(s)
SOFA score
Intervention Description
SOFA score will be performed on all patients before the beginning of the study
Primary Outcome Measure Information:
Title
Evaluation of Gastric Residual Volume(GRV)
Description
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
Time Frame
12 hours
Title
Volume of the gastric antrum
Description
After five half-lives of drugs, the volume of the gastric antrum of the patients will be measured by ultrasonography 3 hours after gavage.
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Blood albumin
Description
blood sampling daily for four days
Time Frame
4 days
Title
Complete Blood Count
Description
blood sampling daily for four days
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED A SHAMA, MD
Organizational Affiliation
Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharurah Armed Forces Hospital
City
Sharurah
ZIP/Postal Code
000000
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
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