NCT07254715

Effect of Itopride on Semaglutide Gastroparesis

Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Semaglutide-Induced Gastric Motility
• Anesthesia

Interventions

Type	Name	Description
DRUG	Itopride HCI 50 mg	Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
DRUG	Placebo	Daily placebo tablet TID, 1 hour before meals for 7 days

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-11-28
• Last updated: 2025-11-28

Locations

1 site across 1 country: Egypt