Effect of Itopride on Semaglutide Gastroparesis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Itopride HCI 50 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Semaglutide-Induced Gastric Motility, Anesthesia. Basic parameters: 40 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Residual gastric contents [Time frame: on day 7]
Secondary outcome measures (2)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- faculty of medicine, Ain Shams University — Cairo
Identifiers
NCT: NCT07254715 · FMASU R263/2025