Delayed Gastric EmptyingPhase 2NCT05342818
Evaluating Neostigmine Effect on Reducing Gastric Residual Volume as Compared With Metoclopramide and Ondansetron
A Phase 2 study testing Neostigmine, Ondansetron 8mg and Metoclopramide Injection in people with Delayed Gastric Emptying, run by Tanta University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Delayed Gastric Emptying
- What is being tested?
- Neostigmine, Ondansetron 8mg and Metoclopramide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2022to 17 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated ICU patients
- With nasogastric tube feeding
- Gastric Residual Volume >120 mL (3hours after the last gavage)
Who cannot join
- 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
Show all 10Show fewer
- Recent surgery (10 days or less) on the stomach or digestive system
- pregnancy and lactation
- Occurrence of extrapyramidal side effects
- Gastrointestinal (GI) bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron
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
.
Read the 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.
- Conditions
- Delayed Gastric Emptying
- Being tested
- Neostigmine, Ondansetron 8mg, Metoclopramide Injection, Enteral feeding nutrition, Sequential Organ Failure Assessment (SOFA) score
- Keywords
- gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
Also called Neostigmine injection
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Ondansetron 8mgDrug
Also called Dansetron injection
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Metoclopramide InjectionDrug
Also called primperan injection
will be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs
Enteral feeding nutritionOther
Also called Enteral feeding
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) scoreOther
Also called SOFA score
SOFA score will be performed on all patients before the beginning of the study
| Study group | Role | What they receive |
|---|---|---|
| Group N | Experimental | 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 Receives: Drug: Neostigmine; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score |
| Group O | Experimental | patients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes Receives: Drug: Ondansetron 8mg; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score |
| Group M | Experimental | patients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion Receives: Drug: Metoclopramide Injection; Other: Enteral feeding nutrition; Other: Sequential Organ Failure Assessment (SOFA) score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 hours
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.
Measured: 4 days
Secondary outcomes (2)
Blood albumin
blood sampling daily for four days
Measured: 4 days
Complete Blood Count
blood sampling daily for four days
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Apr 2022
- Primary completion30 Jul 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Gastric EmptyingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
- Investigators
- AHMED A SHAMA, MD, Principal investigator, Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342818
- Sponsor's protocol ID
- IRC112/04/22
- Status last verified
- Oct 2022
- First submitted
- 17 Apr 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neostigmine Effect on Gastric Residual Volume on Mechanically Ventilated Patients in the Intensive Care Unit. A Comparative Controlled Study by Ondansetron
- ClinicalTrials.gov ID
- NCT05342818
- Acronym / sponsor ID
- IRC112/04/22
- Conditions
- Delayed Gastric Emptying
- Keywords
- gastric residual volume, neostigmine, ondansetron, mechanically ventilated patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group N | Experimental | Drug: Neostigmine, Other: Enteral feeding nutrition, Other: Sequential Organ Failure Assessment (SOFA) scorepatients 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 |
| Group O | Experimental | Drug: Ondansetron 8mg, Other: Enteral feeding nutrition, Other: Sequential Organ Failure Assessment (SOFA) scorepatients will receive an intravenous infusion of 8 mg of ondansetron in 100 ml of normal saline once daily for 20 minutes |
| Group M | Experimental | Drug: Metoclopramide Injection, Other: Enteral feeding nutrition, Other: Sequential Organ Failure Assessment (SOFA) scorepatients will receive metoclopramide in a dose of 10 mg in 100 ml of normal saline once daily for 20 minutes by infusion |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mechanically ventilated ICU patients
- With nasogastric tube feeding
- Gastric Residual Volume >120 mL (3hours after the last gavage)
Key exclusion criteria (10 listed)
- History of diabetes
- Heart block
- Bradycardia (heart rate <60/min)
- Systolic blood pressure less than 90 mm Hg
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeostigmineAlso: Neostigmine injectionwill be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs | Drug | Group N |
| Ondansetron 8mgAlso: Dansetron injectionwill be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs | Drug | Group O |
| Metoclopramide InjectionAlso: primperan injectionwill be given by infusion in 20 minutes once daily by a nurse blinded to the study drugs | Drug | Group M |
| Enteral feeding nutritionAlso: Enteral feedingThe 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 | Group M, Group N, Group O |
| Sequential Organ Failure Assessment (SOFA) scoreAlso: SOFA scoreSOFA score will be performed on all patients before the beginning of the study | Other | Group M, Group N, Group O |
Primary outcome
Evaluation of Gastric Residual Volume(GRV)
Time frame: 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
Volume of the gastric antrum
Time frame: 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.
2 secondary outcomes
Blood albumin
Time frame: 4 days
Complete Blood Count
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AHMED A SHAMA, MD principal investigator
Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neostigmine, Ondansetron 8mg and Metoclopramide Injection in people with Delayed Gastric Emptying, run by Tanta University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Gastric Residual Volume(GRV) (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.