Clinical trial NCT05342818: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Delayed Gastric Emptying
Keywords: gastric residual volume
neostigmine
ondansetron
mechanically ventilated patients
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 90
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Evaluation of Gastric Residual Volume(GRV)
timeFrame: 12 hours
measure: Volume of the gastric antrum
timeFrame: 4 days
Secondary outcomes:
measure: Blood albumin
timeFrame: 4 days
measure: Complete Blood Count
timeFrame: 4 days
Other outcomes:
Locations:
city: Sharurah
country: Saudi Arabia
facility: Sharurah Armed Forces Hospital
Study officials:
affiliation: Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
name: AHMED A SHAMA, MD
role: PRINCIPAL_INVESTIGATOR
References: