Itopride to speed stomach emptying in people on semaglutide
Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
This trial tests whether a single dose of itopride before anesthesia helps women with diabetes who take weekly semaglutide and are having elective hysterectomy clear their stomach faster and have less leftover stomach content after an 8-hour fast.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 60 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07254715 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized, double-blind, placebo-controlled study at Ain Shams University comparing itopride 50 mg to placebo in adults on weekly semaglutide who are scheduled for elective hysterectomy. Participants are women aged 40–60 with BMI 20–30 kg/m2 and ASA physical status I–III. Gastric ultrasound will be performed after an 8-hour fast before anesthesia to measure residual gastric contents and gastric motility. The trial tests whether giving itopride before surgery reduces residual gastric volume compared with placebo.
Who should consider this trial
Good fit: Women aged 40–60 with type 2 diabetes on weekly semaglutide (0.5–1 mg) who are scheduled for elective hysterectomy, ASA I–III, BMI 20–30, and without the listed exclusion conditions are ideal candidates.
Not a fit: People with prior upper abdominal surgery or hiatal hernia, those taking other medications that slow gastric emptying, patients with cardiac arrhythmias, significant hepatic or renal failure, neurologic disease, or known allergy to itopride are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, itopride could reduce leftover stomach contents before anesthesia in patients on semaglutide, lowering the risk of aspiration and helping surgery proceed more safely and promptly.
How similar studies have performed: Prokinetic drugs, including itopride, have been shown to speed gastric emptying in other indications, but using itopride specifically to counter semaglutide-related delayed gastric emptying before anesthesia has limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, Cairo Governorate
- faculty of medicine, Ain Shams University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: tamer Samir abdelaziz, MD
- Email: drtasamir@hotmail.com
- Phone: +201154601505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.