Clinical trial

Effect of Itopride on Semaglutide Gastroparesis

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07254715

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age40 Years to 60 Years

SexFemale

Healthy volunteersNot accepted

ConditionSemaglutide-Induced Gastric Motility, Anesthesia

Full registry 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.

Treatments and study arms

Itopride HCI 50 mg

Drug

Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days

Placebo

Drug

Daily placebo tablet TID, 1 hour before meals for 7 days

Primary outcomes

Residual gastric contentson day 7

Residual gastric contents (clear fluid ˃1.5 mL/kg or the presence of solids) by ultrasound in the right lateral decubitus after 8-hours fasting .

Study locations

1 locations were listed when this page was built. The first 40 are shown.

faculty of medicine, Ain Shams University🇪🇬 Cairo, Cairo Governorate, Egypt

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tamer abdelazizContact

Email · Call +201154601505

tamer samir abdelazizContact

Email · Call 00201154601505

tamer S abdelaziz, MDPrincipal Investigator