Gastric RefluxGastricNCT06687187
Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients
An observational study of Gastric Reflux, run by Zulekha Hospitals at 1 site in Egypt.
Trial summary
A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Gastric Reflux
- What is being tested?
- Neostigmine
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 May 2024
- Phase
- Observational
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study included 124 patients aged between 20 and 60 years requiring enteral feeding via nasogastric (NG) or orogastric (OG) tubes
Who may be able to join
- patients with a GRV >120ml
- a normal heart rateExclusion Criteria
- absence of comorbidities such as diabetes and renal failure. exclusion Criteria:
- Patients exhibiting new-onset arrhythmias or heart block
- hypotension (systolic blood pressure less than 60 mmHg)
- experiencing active gastrointestinal bleeding or receiving prokinetic medications 8-12 hours before the intervention
Show all 9Show fewer
- patients with a history of surgery in the gastrointestinal system in the past two weeks history of extrapyramidal manifestations
- patients with electrolyte imbalance
- pregnant patients,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients Under Enteral Feeding; a Comparative Controlled Randomized Trial
A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding.
Read the detailed description
Participants were categorized into three groups: Group I and Group II received neostigmine 1 mg and 2 mg, respectively, and a control group received 10 ml of normal saline. All participants received an intravenous administration of 10 mg of metoclopramide. GRV was measured every 3 hours before enteral feeding. aspiration through nasogastric (NG) or orogastric (OG) tubes was done before the next due bolus of feeding.
- Conditions
- Gastric Reflux
- Being tested
- Neostigmine
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeostigmineDrug
two groups (Group I, n= 41) and (Group II, n= 43) received varying doses of neostigmine (1 mg and 2 mg respectively
| Study group | Role | What they receive |
|---|---|---|
| Group I | received neostigmine 1 mg Receives: Drug: Neostigmine | |
| Group II | received neostigmine 2 mg Receives: Drug: Neostigmine | |
| Group III | received normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of aspiration
The risk of aspiration in ICU patients on enteral feeding via vaso-gastric or oro-hastric tubes
Measured: december 2022 to may 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start1 Dec 2022
- Primary completion1 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric RefluxStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zulekha Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- abdalla e hassan, lecturer, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06687187
- Sponsor's protocol ID
- 382/46
- Acronym
- Gastric
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Doses of Neostigmine on the Gastric Residual Volume and Aspiration in Critically Ill Patients Under Enteral Feeding; a Comparative Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT06687187
- Acronym / sponsor ID
- Gastric / 382/46
- Conditions
- Gastric Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Zulekha HospitalsUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 13 Nov 2024 (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.
A study comparing the effect of two doses of neostigmine on the gastric residual volume in critically ill patients on enteral feeding.
Detailed description
Participants were categorized into three groups: Group I and Group II received neostigmine 1 mg and 2 mg, respectively, and a control group received 10 ml of normal saline. All participants received an intravenous administration of 10 mg of metoclopramide. GRV was measured every 3 hours before enteral feeding. aspiration through nasogastric (NG) or orogastric (OG) tubes was done before the next due bolus of feeding.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Drug: Neostigminereceived neostigmine 1 mg |
| Group II | – | Drug: Neostigminereceived neostigmine 2 mg |
| Group III | – | –received normal saline |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included 124 patients aged between 20 and 60 years requiring enteral feeding via nasogastric (NG) or orogastric (OG) tubes
Key inclusion criteria (9 listed)
- patients with a GRV >120ml
- a normal heart rateExclusion Criteria
- absence of comorbidities such as diabetes and renal failure. exclusion Criteria:
- Patients exhibiting new-onset arrhythmias or heart block
- hypotension (systolic blood pressure less than 60 mmHg)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Neostigminetwo groups (Group I, n= 41) and (Group II, n= 43) received varying doses of neostigmine (1 mg and 2 mg respectively | Drug | Group I, Group II |
Primary outcome
The risk of aspiration
Time frame: december 2022 to may 2024
The risk of aspiration in ICU patients on enteral feeding via vaso-gastric or oro-hastric tubes
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 13 Nov 2024.
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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.
abdalla e hassan, lecturer principal investigator
lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Reflux, run by Zulekha Hospitals at 1 site in Egypt.
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 9 inclusion and 0 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 13 Nov 2024. 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 Egypt. 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.
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?
The risk of aspiration (time frame: december 2022 to may 2024). 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 13 Nov 2024.