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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RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2025-12-31
2026-04-30
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Itopride HCL
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Itopride HCI 50 mg
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days
Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days
Interventions
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Itopride HCI 50 mg
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days
Eligibility Criteria
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Inclusion Criteria
* Age: 40-60 years.
* BMI: 20-30 kg/m2.
* Diabetic patients on semaglutide (0.5-1mg) SC weekly.
* Undergoing elective hysterectomy.
Exclusion Criteria
* 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.
40 Years
60 Years
FEMALE
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Tamer Samir Abdelsalam
Assistant professor of anesthesia, Intensive care and Pain medicine
Locations
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faculty of medicine, Ain Shams University
Cairo, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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tamer abdelaziz
Role: primary
tamer samir abdelaziz
Role: backup
Other Identifiers
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FMASU R263/2025
Identifier Type: -
Identifier Source: org_study_id