Effect of Itopride on Semaglutide Gastroparesis

November 25, 2025 updated by: Tamer Samir Abdelsalam, Ain Shams University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11591
        • Recruiting
        • Faculty of Medicine, Ain Shams University
        • Contact:
        • Contact:
        • Principal Investigator:
          • tamer S abdelaziz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Itopride HCL
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Drug: Itopride HCI 50 mg
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Placebo Comparator: Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days
Drug: Placebo
Daily placebo tablet TID, 1 hour before meals for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
on day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Residual gastric contents on day 3 and day 5.
Time Frame: on day 3 and day 5
on day 3 and day 5
Incidence of vomiting during anesthesia
Time Frame: during anesthesia
during anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FMASU R263/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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