Gastric Residual VolumeNCT04682691
Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume
A study testing Erythromycin (400mg), metoclopramide (10mg) and naturally flavored water in people with Gastric Residual Volume, run by Cairo University at 1 site in Egypt.
Trial summary
In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastric Residual Volume
- What is being tested?
- Erythromycin (400mg), metoclopramide (10mg) and naturally flavored water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 22 Feb 2024
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-laboring pregnant women ≥36 weeks gestational age
- Parturient scheduled for elective caesarian delivery.
- Singleton pregnancy
- Age greater than 18 years
- Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food)
- 2. Exclusion criteria:
Show all 22Show fewer
- Refusal of the patient
- Deviation from fasting times
- Patients with empty stomach
- Emergency operation
- Body mass index (BMI) greater than 40 kg/m2
- American Society of Anesthesiologists (ASA) physical status class III, IV.
- Gestational diabetes mellitus
- Multiple gestations
- Patients with polyhydramnios liquor.
- Preeclampsia patients
- Chronic kidney disease patients
- Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis).
- Patients with gastrointestinal diseases such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries.
- Patients on antidepressants and monoamine oxidase inhibitors
- Use of other medications known to affect gastric motility or secretions.
- Allergy to macrolide or metoclopramide
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume
In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women
- Conditions
- Gastric Residual Volume
- Being tested
- Erythromycin (400mg), metoclopramide (10mg), naturally flavored water
- Keywords
- Erythromycin, Gastric Emptying, Metoclopramide, Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythromycin (400mg)Drug
oral Erythromycin (400mg)
metoclopramide (10mg)Drug
oral metoclopramide (10mg)
naturally flavored waterDietary supplement
naturally flavored water
| Study group | Role | What they receive |
|---|---|---|
| Group (C) | Sham comparator | will be receive flavored water in total volume 15 ml Receives: Dietary Supplement: naturally flavored water |
| Group (M) | Active comparator | will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml Receives: Drug: metoclopramide (10mg) |
| Group (E) | Active comparator | will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml Receives: Drug: Erythromycin (400mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Gastric volume
(ml/kg) after a six-hour fast using Roukhomovsky's equation after administration of the study drug.
Measured: UP TO 6 HOURE
Secondary outcomes (4)
low-risk stomach six hours after drug administration
number of patient and %
Measured: up to 6 hours
Perlas grading system
Grade 0 antrum: absent fluid content in both supine and RLD positions Grade 1 antrum: fluid is observed only in the RLD position, but not in the supine position Grade 2 antrum: fluid is observed in both supine and RLD
Measured: UP TO 24 HOURE
Evaluation of the risk of aspiration
residual gastric volume < 1.5 mL/kg
Measured: UP TO 24 HOURE
quantitative gastric contents
every one hours estimated GV till ( < 1.5 ml/kg) post-drug administration
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Mar 2021
- Primary completion5 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Samir Wahdan, Cairo University
- Investigators
- Amr wahdan, MD, Principal investigator, Cairo university , Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682691
- Sponsor's protocol ID
- MS-381-2020
- Status last verified
- Jan 2025
- First submitted
- 19 Dec 2020
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume
- ClinicalTrials.gov ID
- NCT04682691
- Acronym / sponsor ID
- MS-381-2020
- Conditions
- Gastric Residual Volume
- Keywords
- Erythromycin, Gastric Emptying, Metoclopramide, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 24 Dec 2020 (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.
In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (C) | Sham comparator | Dietary Supplement: naturally flavored waterwill be receive flavored water in total volume 15 ml |
| Group (M) | Active comparator | Drug: metoclopramide (10mg)will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml |
| Group (E) | Active comparator | Drug: Erythromycin (400mg)will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Non-laboring pregnant women ≥36 weeks gestational age
- Parturient scheduled for elective caesarian delivery.
- Singleton pregnancy
- Age greater than 18 years
- Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food)
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 |
|---|---|---|
| Erythromycin (400mg)oral Erythromycin (400mg) | Drug | Group (E) |
| metoclopramide (10mg)oral metoclopramide (10mg) | Drug | Group (M) |
| naturally flavored waternaturally flavored water | Dietary supplement | Group (C) |
Primary outcome
Estimated Gastric volume
Time frame: UP TO 6 HOURE
(ml/kg) after a six-hour fast using Roukhomovsky's equation after administration of the study drug.
4 secondary outcomes
low-risk stomach six hours after drug administration
Time frame: up to 6 hours
Perlas grading system
Time frame: UP TO 24 HOURE
Evaluation of the risk of aspiration
Time frame: UP TO 24 HOURE
quantitative gastric contents
Time frame: up to 24 hours
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 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Gastric Residual Volume
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Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
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Effect of Prolonged Fasting Time on Gastric Residual Volume in Patients Taking GLP1 Receptor Agonists
Upper Endoscopy, GLP1-R-related Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (DM), Gastric Ultrasound
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Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
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Gastric Emptying and Enteral Nutrition Tolerance According to Vasopressor Dose in ICU Patients
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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.
Amr wahdan, MD principal investigator
Cairo university , Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erythromycin (400mg), metoclopramide (10mg) and naturally flavored water in people with Gastric Residual Volume, run by Cairo University 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 22 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 14 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Estimated Gastric volume (time frame: UP TO 6 HOURE). 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 14 Jan 2025.