Study of Effects of Preoperative Oral Domperidone on Gastric Residual Volume After Clear Fluid Ingestion in Patients Scheduled for Elective Surgeries

Study Overview
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Brief Summary
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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 (

Official Title
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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

Conditions
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Gastric Residual Volume

Intervention / Treatment
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* Drug: Domperidone
* Drug: Folic acid


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Domperidone<br> | Drug: Domperidone<br>* ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of domperidone tablet<br>|
| Placebo Comparator: Folic acid<br> | Drug: Folic acid<br>* ultrasound guieded assesment of gastric residual volume will be done 2 h after oral injestion of folic acid tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assess the effect of oral Domperidone preoperatively on gastric residual volume by ultrasound for patients undergoing elective surgeries under general anesthesia | patients will receive 400 ml of apple juice as a clear fluid, two hours preoperatively, and oral Domperidone tab or placebo tab | first 2 hours preoperative |