Effect of Itopride on Semaglutide Gastroparesis

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Semaglutide-Induced Gastric Motility; Anesthesia

Treatments: Drug: Itopride HCI 50 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07254715

FMASU R263/2025

Details and patient eligibility

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Itopride HCL

Active Comparator group

Description:

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

Treatment:

Drug: Itopride HCI 50 mg

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo