Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07254715

Effect of Itopride on Semaglutide Gastroparesis

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Residual gastric contents

    Time frame: on 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 .

Secondary outcomes

  1. Residual gastric contents on day 3 and day 5.

    Time frame: on day 3 and day 5

  2. Incidence of vomiting during anesthesia

    Time frame: during anesthesia

Study contacts

Contact information is provided by the study sponsor or research team.

tamer Samir abdelaziz, MD

CONTACT

[email protected]

+201154601505

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.