Effect of Itopride on Semaglutide Gastroparesis

Phase 4RecruitingNCT07254715

Ain Shams University60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Semaglutide-Induced Gastric Motility Anesthesia

Interventions

Itopride HCI 50 mgDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

faculty of medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

Residual gastric contents

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 .

Time frame: on day 7

Secondary Outcomes

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

Central Contacts

tamer Samir abdelaziz, MD

CONTACT

+201154601505 drtasamir@hotmail.com

Data from ClinicalTrials.gov

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