Ultrasound Assessment of Metoclopramide's Effect on Stomach Volume in Urgent Pediatric Trauma Surgery
NCT ID: NCT06793267
Last Updated: 2025-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
70 participants
INTERVENTIONAL
2025-02-15
2026-03-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group1
patients will receive 0.15mg/kg metoclopramide intravenously diluted in 2 ml.
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.
Group 2
Participants will receive a placebo in the form of 2 ml of normal saline administered intravenously.
Saline
patients will recive normal saline 0.9% 2ml intravenous
Interventions
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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.
Saline
patients will recive normal saline 0.9% 2ml intravenous
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of head trauma.
0 Years
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Rasha Ahmed Ali Hamed
Doctor
Central Contacts
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References
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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.
Howard FA, Sharp DS. Effect of metoclopramide on gastric emptying during labour. Br Med J. 1973 Feb 24;1(5851):446-8.
Adelhoj 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.
simeneh 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.
Paranjothy 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.
Kruisselbrink 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.
Van 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.
Other Identifiers
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USAMEGVUSTP
Identifier Type: -
Identifier Source: org_study_id
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