Anesthesia, Semaglutide-Induced Gastric Motility
Conditions
Keywords
itopride, gastric ultrasound
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.
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.
Interventions
Daily oral 50mg Itopride tablet TID, 1 hour before meals for 7 days
DRUGPlacebo
Daily placebo tablet TID, 1 hour before meals for 7 days
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual gastric contents | 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
| Measure | Time frame |
|---|---|
| Residual gastric contents on day 3 and day 5. | on day 3 and day 5 |
| Incidence of vomiting during anesthesia | during anesthesia |
Countries
Egypt
Contacts
Primary Contacttamer Samir abdelaziz, MD
Outcome results
None listed