Actively Recruiting
Does Itopride Improve Semaglutide Induced Gastroparesis Before Anesthesia? Randomized Controlled Trial
Led by Ain Shams University · Updated on 2025-11-28
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of Itopride on gastroparesis caused by Semaglutide, a medication used in type 2 diabetes and obesity treatment. Semaglutide delays gastric emptying and increases the risk of aspiration during anesthesia, which the study intends to address by testing if Itopride can improve gastric emptying and reduce residual stomach contents before surgery. Participants will be randomly assigned to receive either oral Itopride tablets or placebo tablets three times daily, one hour before meals, for seven days. The study is designed as a prospective, randomized, double-blind controlled trial focusing on women aged 40 to 60 years undergoing elective hysterectomy and using Semaglutide. During the study, researchers will use gastric ultrasound to assess residual gastric contents after eight hours of fasting on days 3, 5, and 7 before anesthesia. They will also monitor the incidence of vomiting during anesthesia. The trial includes safety monitoring and will last through the treatment period, with the primary measurement taken on day 7.
CONDITIONS
Brief Title
Effect of Itopride on Semaglutide Gastroparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 40 to 60 years
- American Society of Anesthesiologists grade I to III
- Body mass index between 20 and 30 kg/m2
- Diagnosed with type 2 diabetes and using Semaglutide (0.5-1mg) subcutaneously weekly
- Scheduled for elective hysterectomy
You will not qualify if you...
- Declines to provide written informed consent
- History of upper abdominal surgery or presence of hiatal hernia
- Use of medications known to cause gastroparesis such as opioids, proton pump inhibitors, tricyclic antidepressants, calcium channel blockers, antipsychotics, or lithium
- Allergy to Itopride
- History of cardiac arrhythmia or abnormal ECG
- Neurologic diseases including Parkinson's disease or multiple sclerosis
- Liver or kidney failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take either Itopride or placebo tablets three times daily for 7 days before surgery to evaluate the effect on gastric emptying.
Visits on day 3, day 5, and day 7 during treatment
Trial Site Locations
Total: 1 location
1
faculty of medicine, Ain Shams University
Cairo, Cairo Governorate, Egypt, 11591
Actively Recruiting
Research Team
T
tamer Samir abdelaziz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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