Clinical trial

Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries: Prospective , Randomized ,Double Blinded Controlled Study

Name
FMASU MS210/2022
Description
General Anesthesia requires preoperative fasting according to specific instructions. Regarding Fasting Guidelines, The American Society of Anesthesiologists (ASA) recommends patients to fast from fatty food or meat eight hours prior to surgery, non-human milk or light meal for six hours prior, breast milk for four hours prior, and clear liquids including water, pulp-free juice, and tea without milk for two hours prior to the anesthetic. ASA fasting guidelines application represents the primary method to avoid aspiration as it ensures that stomach is empty before induction of anesthesia. These guidelines cannot be applied on all cases as in urgent or emergent situations or in morbidities associated with delayed gastric emptying, like Diabetes mellitus and some neurological disorders (
Trial arms
Trial start
2022-10-10
Estimated PCD
2023-04-20
Trial end
2023-04-20
Status
Completed
Phase
Early phase I
Treatment
Domperidone
ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet
Arms:
Domperidone
Folic acid
ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet
Arms:
Folic acid
Size
40
Primary endpoint
assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia
first 2 hours preoperative
Eligibility criteria
Inclusion Criteria: * Patients of both sexes * aged between 18-65 years * who are categorized by ASA physical status as I or II * undergoing elective surgeries under general anesthesia Exclusion Criteria: * Patients with known or suspected delayed gastric emptying (e.g. Diabetes mellitus) -psychiatric disorders * hypersensitivity to the study medications * peoples undergoing surgeries that associated with high incidence of Post operative nausea and vomiting (PONV) (e.g. Cholecystectomy, gynecological, ophthalmological, otorhinolaryngological, and laparoscopic surgeries).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-05-15

1 organization

2 products

1 indication

Product
Folic acid