Gastric VolumePhase 3NCT06793267
Ultrasound Assessment of Metoclopramide's Effect on Stomach Volume in Urgent Pediatric Trauma Surgery
A Phase 3 study testing Metoclopramide (Maxolon) and Saline in people with Gastric Volume, run by Assiut University.
Trial summary
assess the efficacy of metoclopramide in reducing the gastric contents and volume in pediatric trauma prepared for urgent surgical interventions. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Gastric Volume
- What is being tested?
- Metoclopramide (Maxolon) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Mar 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Paediatric urgent trauma
Who cannot join
- Guardian' refusal.
- Presence of head trauma.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasonoraphic Asessment of Metoclopramide Effect on Gastric Volume in Urgent Surgical Trauma Pediateric Patients. Randomozed Controlled Double Blind Study.
assess the efficacy of metoclopramide in reducing the gastric contents and volume in pediatric trauma prepared for urgent surgical interventions.
Read the detailed description
Gastric volume is a critical consideration in pediatric patients undergoing urgent surgical procedures, particularly in trauma cases where rapid sequence induction is required to minimize the risk of aspiration. Point-of-care gastric ultrasonography (gastric PocUs) allows evaluation of the volume and type of stomach contents. Previous studies have reported that gastric contents and volume measured using gastric PoCUS are significantly correlated with cross-sectional antral area. as a result, bedside gastric PocUs is considered a reliable and reproducible technique. gastric PocUs scan can distinguish an empty stomach from a full stomach based on qualitative results by distinguishing the physical properties of gastric fluid. The presence of thick fluid and solid contents indicate a full stomach.in contrast, the presence of clear gastric fluid is normal in healthy, fasted individuals at low risk of aspiration. as a result, assessing the volume of clear fluid in the stomach may have utility in identifying high stomach volumes that are incompatible with the fasting state.
Metoclopramide is a prokinetic chlorobenzamide derivative that accelerates gastric emptying and reduces gastric volume. Metoclopramide can be safely used preoperatively prior to cesarean section (cs). Metoclopramide has been extensively studied as a premedication for abdominal surgery, particularly in obstetric populations. Due to favorable effect of reducing gastric fluid volume, metoclopramide is commonly used to reduce the risk of aspiration pneumonia during surgery. Metoclopramide reportedly has synergistic dual activity in parturient women; an antiemetic effect on the chemoreceptor trigger zone and peripheral activity in increasing the tone of the lower esophageal sphincter and decreasing the time required for gastric emptying. the mortality of aspiration pneumonia-related is reportedly as high as 5%, with aspiration pneumonia responsible for up to 9% of all anesthesia-related deaths. Metoclopramide is well known for its ability to enhance gastric emptying however, to the best of our knowledge, the effectiveness of metoclopramide in enhancing gastric emptying has yet to be evaluated with ultrasonography in preoperative settings, particularly in urgent pediatric trauma.
- Conditions
- Gastric Volume
- Being tested
- Metoclopramide (Maxolon), Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoclopramide (Maxolon)Drug
Participants will receive 0.15 mg/kg of metoclopramide administered intravenously. The drug will be diluted in 2 ml of solution prior to administration.
SalineDrug
patients will recive normal saline 0.9% 2ml intravenous
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Active comparator | patients will receive 0.15mg/kg metoclopramide intravenously diluted in 2 ml. Receives: Drug: Metoclopramide (Maxolon) |
| Group 2 | Placebo comparator | Participants will receive a placebo in the form of 2 ml of normal saline administered intravenously. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum
Ultrasonographic evaluation was performed to study the impact of metoclopramide on the morphology of the gastric antrum. The cross-sectional area (CSA) of the antrum was calculated using the Bolondi et al. method with the formula:Antral CSA = π (AP × CC) / 4
Measured: baseline
Secondary outcomes (1)
effect of metoclopramide on gastric grading was assessed using a three-point grading systems
The effect of metoclopramide on gastric grading was evaluated using a three-point grading system as follows:
G-0: The antrum is flat and empty in both supine and right lateral positions (RLP).
G-1: The antrum contains fluid in the right lateral position but is empty in the supine position.
G-2: The antrum contains fluid in both supine and right lateral positions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gastric VolumeStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Ahmed Ali Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793267
- Sponsor's protocol ID
- USAMEGVUSTP
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.
PubMed 3896910Howard FA, Sharp DS. Effect of metoclopramide on gastric emptying during labour. Br Med J. 1973 Feb 24;1(5851):446-8.
PubMed 4689832Adelhoj B, Petring OU, Pedersen NO, Andersen RD, Busch P, Vestergard AS. Metoclopramide given pre-operatively empties the stomach. Acta Anaesthesiol Scand. 1985 Apr;29(3):322-5. doi: 10.1111/j.1399-6576.1985.tb02208.x.
PubMed 3993321simeneh endalew EN, gebremedhn eg, gebreegzi aH, gebreegzi AH, Kassahun HG, Kassa AA, et al. effectiveness of intravenous metoclopramide prophylaxis on the reduction of intraoperative and early postoperative nausea and vomiting after emergency caesarean section under spinal anaesthesia. J anesth clin res 2018;09:2.
O'Sullivan G, Sear JW, Bullingham RE, Carrie LE. The effect of magnesium trisilicate mixture, metoclopramide and ranitidine on gastric pH, volume and serum gastrin. Anaesthesia. 1985 Mar;40(3):246-53. doi: 10.1111/j.1365-2044.1985.tb10750.x.
PubMed 2986474Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4.
PubMed 24497372Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
PubMed 29624530Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
PubMed 24893784
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonoraphic Asessment of Metoclopramide Effect on Gastric Volume in Urgent Surgical Trauma Pediateric Patients. Randomozed Controlled Double Blind Study.
- ClinicalTrials.gov ID
- NCT06793267
- Acronym / sponsor ID
- USAMEGVUSTP
- Conditions
- Gastric Volume
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 27 Jan 2025 (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.
assess the efficacy of metoclopramide in reducing the gastric contents and volume in pediatric trauma prepared for urgent surgical interventions.
Detailed description
Gastric volume is a critical consideration in pediatric patients undergoing urgent surgical procedures, particularly in trauma cases where rapid sequence induction is required to minimize the risk of aspiration. Point-of-care gastric ultrasonography (gastric PocUs) allows evaluation of the volume and type of stomach contents. Previous studies have reported that gastric contents and volume measured using gastric PoCUS are significantly correlated with cross-sectional antral area. as a result, bedside gastric PocUs is considered a reliable and reproducible technique. gastric PocUs scan can distinguish an empty stomach from a full stomach based on qualitative results by distinguishing the physical properties of gastric fluid. The presence of thick fluid and solid contents indicate a full stomach.in contrast, the presence of clear gastric fluid is normal in healthy, fasted individuals at low risk of aspiration. as a result, assessing the volume of clear fluid in the stomach may have utility in identifying high stomach volumes that are incompatible with the fasting state.
Metoclopramide is a prokinetic chlorobenzamide derivative that accelerates gastric emptying and reduces gastric volume. Metoclopramide can be safely used preoperatively prior to cesarean section (cs). Metoclopramide has been extensively studied as a premedication for abdominal surgery, particularly in obstetric populations. Due to favorable effect of reducing gastric fluid volume, metoclopramide is commonly used to reduce the risk of aspiration pneumonia during surgery. Metoclopramide reportedly has synergistic dual activity in parturient women; an antiemetic effect on the chemoreceptor trigger zone and peripheral activity in increasing the tone of the lower esophageal sphincter and decreasing the time required for gastric emptying. the mortality of aspiration pneumonia-related is reportedly as high as 5%, with aspiration pneumonia responsible for up to 9% of all anesthesia-related deaths. Metoclopramide is well known for its ability to enhance gastric emptying however, to the best of our knowledge, the effectiveness of metoclopramide in enhancing gastric emptying has yet to be evaluated with ultrasonography in preoperative settings, particularly in urgent pediatric trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Active comparator | Drug: Metoclopramide (Maxolon)patients will receive 0.15mg/kg metoclopramide intravenously diluted in 2 ml. |
| Group 2 | Placebo comparator | Drug: SalineParticipants will receive a placebo in the form of 2 ml of normal saline administered intravenously. |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Paediatric urgent trauma
Key exclusion criteria (2 listed)
- Guardian' refusal.
- Presence of head trauma.
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 |
|---|---|---|
| Metoclopramide (Maxolon)Participants will receive 0.15 mg/kg of metoclopramide administered intravenously. The drug will be diluted in 2 ml of solution prior to administration. | Drug | Group1 |
| Salinepatients will recive normal saline 0.9% 2ml intravenous | Drug | Group 2 |
Primary outcome
ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum
Time frame: baseline
Ultrasonographic evaluation was performed to study the impact of metoclopramide on the morphology of the gastric antrum. The cross-sectional area (CSA) of the antrum was calculated using the Bolondi et al. method with the formula:Antral CSA = π (AP × CC) / 4
1 secondary outcome
effect of metoclopramide on gastric grading was assessed using a three-point grading systems
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Results publication: PubMed 3896910Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.
- Results publication: PubMed 4689832Howard FA, Sharp DS. Effect of metoclopramide on gastric emptying during labour. Br Med J. 1973 Feb 24;1(5851):446-8.
- Results publication: PubMed 3993321Adelhoj B, Petring OU, Pedersen NO, Andersen RD, Busch P, Vestergard AS. Metoclopramide given pre-operatively empties the stomach. Acta Anaesthesiol Scand. 1985 Apr;29(3):322-5. doi: 10.1111/j.1399-6576.1985.tb02208.x.
- Results publicationsimeneh endalew EN, gebremedhn eg, gebreegzi aH, gebreegzi AH, Kassahun HG, Kassa AA, et al. effectiveness of intravenous metoclopramide prophylaxis on the reduction of intraoperative and early postoperative nausea and vomiting after emergency caesarean section under spinal anaesthesia. J anesth clin res 2018;09:2.
- Results publication: PubMed 2986474O'Sullivan G, Sear JW, Bullingham RE, Carrie LE. The effect of magnesium trisilicate mixture, metoclopramide and ranitidine on gastric pH, volume and serum gastrin. Anaesthesia. 1985 Mar;40(3):246-53. doi: 10.1111/j.1365-2044.1985.tb10750.x.
- Results publication: PubMed 24497372Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4.
- Results publication: PubMed 29624530Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.
- Results publication: PubMed 24893784Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoclopramide (Maxolon) and Saline in people with Gastric Volume, run by Assiut University.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doctor (+20 1152800305, Fahd.16266304@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06793267, which also lists 8 linked publications.
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 27 Jan 2025.