A Phase 4 interventional study of Itopride HCI 50 mg and Placebo in Semaglutide-Induced Gastric Motility and Anesthesia, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride, could enhance gastric emptying and hasten surgery.
The investigator will evaluate the effect of Itopride on Semaglutide-induced gastroparesis and residual gastric contents after 8 hours of fasting by gastric ultrasound before anesthesia.
Semaglutide delays gastric emptying and increases the risk of aspiration with anesthesia; So, the addition of prokinetics as Itopride could enhance gastric emptying and hastens surgery.
Semaglutide, a glucagon-like peptide-1 (GLP-1) agonist, is gaining popularity for the treatment of type 2 diabetes mellitus (T2DM) and obesity; Semaglutide stimulates insulin excretion and delays gastric emptying.Itopride, a novel prokinetic agent, acts as a dopamine D2 receptor antagonist and an acetylcholine esterase inhibitor. Itopride shows promise in managing gastroparesis symptoms by accelerating gastric emptying, improving gastric tension and sensitivity, and exerting antiemetic effects.
The investigator designed this prospective, randomized, double-blind controlled study to evaluate the effect of Itopride on Semaglutide induced gastroparesis and residual gastric contents after 8-hours fasting by gastric ultrasound before anesthesia.
Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Drug: Itopride HCI 50 mg
Daily placebo tablet TID, 1 hour before meals for 7 days
Drug: Placebo
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Daily placebo tablet TID, 1 hour before meals for 7 days
Residual gastric contents
Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting .
Time frame: on day 7
Residual gastric contents on day 3 and day 5.
Time frame: on day 3 and day 5
Incidence of vomiting during anesthesia
Time frame: during anesthesia
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Ain Shams University