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

Delayed Gastric Emptying Clinical Trial

Official title:

Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05342818
• Other study ID #: IRC112/04/22
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: October 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 17, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Gastric Emptying
• Gastroparesis

Intervention

Drug:
• 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

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
• Sequential Organ Failure Assessment (SOFA) score
SOFA score will be performed on all patients before the beginning of the study

Locations

Country	Name	City	State
Saudi Arabia	Sharurah Armed Forces Hospital	Sharurah

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood albumin	blood sampling daily for four days	4 days
Secondary	Complete Blood Count	blood sampling daily for four days	4 days