NCT07254715 Effect of Itopride on Semaglutide Gastroparesis
| NCT ID | NCT07254715 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ain Shams University |
| Condition | Semaglutide-Induced Gastric Motility |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2025-12 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * American Society of Anesthesiologists grade I- III. * Age: 40-60 years. * BMI: 20-30 kg/m2. * Diabetic patients on semaglutide (0.5-1mg) SC weekly. * Undergoing elective hysterectomy. Exclusion Criteria: * Declining to give written informed consent. * history of upper abdominal surgery or the presence of hiatal hernia. * Other medications inducing gastroparesis (opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotic medications, and lithium). * History of allergy to Itopride. * History of cardiac arrhythmia or abnormal ECG. * Neurologic diseases (including Parkinson's disease and multiple sclerosis) * Hepatic or renal failure.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07254715 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 60 Years, studying Semaglutide-Induced Gastric Motility. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07254715 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07254715 currently recruiting?
Yes, NCT07254715 is actively recruiting participants. Contact the research team at drtasamir@hotmail.com for enrollment information.
Where is the NCT07254715 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07254715 clinical trial?
NCT07254715 is sponsored by Ain Shams University. The trial plans to enroll 60 participants.