Effect of Itopride on Semaglutide Gastroparesis
Does Itopride Improve Semaglutide Induced Gastroparesis Ultrasound Before Anesthesia? Randomized Controlled Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2025
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
November 28, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedNovember 28, 2025
November 1, 2025
4 months
November 19, 2025
November 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 .
on day 7
Secondary Outcomes (2)
Residual gastric contents on day 3 and day 5.
on day 3 and day 5
Incidence of vomiting during anesthesia
during anesthesia
Study Arms (2)
Itopride HCL
ACTIVE COMPARATORDaily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Placebo
PLACEBO COMPARATORDaily placebo tablet TID, 1 hour before meals for 7 days
Interventions
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
faculty of medicine, Ain Shams University
Cairo, Cairo Governorate, 11591, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor of anesthesia, Intensive care and Pain medicine
Study Record Dates
First Submitted
November 19, 2025
First Posted
November 28, 2025
Study Start
December 1, 2025
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
November 28, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share