Effect on Gastric Residual Volume

Study Overview
=================
Brief Summary
-----------------
In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women

Official Title
-----------------
Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume

Conditions
-----------------
Gastric Residual Volume

Intervention / Treatment
-----------------
* Drug: Erythromycin (400mg)
* Drug: metoclopramide (10mg)
* Dietary Supplement: naturally flavored water


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-laboring pregnant women ≥36 weeks gestational age Parturient scheduled for elective caesarian delivery. Singleton pregnancy Age greater than 18 years Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food) 2. Exclusion criteria: Refusal of the patient Deviation from fasting times Patients with empty stomach Emergency operation Body mass index (BMI) greater than 40 kg/m2 American Society of Anesthesiologists (ASA) physical status class III, IV. Gestational diabetes mellitus Multiple gestations Patients with polyhydramnios liquor. Preeclampsia patients Chronic kidney disease patients Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis). Patients with gastrointestinal diseases such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries. Patients on antidepressants and monoamine oxidase inhibitors Use of other medications known to affect gastric motility or secretions. Allergy to macrolide or metoclopramide

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group (C)<br>who will receive flavored water in total volume 15 ml at two hours preoperative. | Dietary Supplement: naturally flavored water<br>* will be receive naturally flavored water<br>|
| Active Comparator: Group (M)<br>will be receive 10 ml of oral metoclopramide (10mg) | Drug: metoclopramide (10mg)<br>* will be receive oral metoclopramide (10mg)<br>|
| Active Comparator: Group (E)<br>will receive 10 ml of oral Erythromycin (400mg) | Drug: Erythromycin (400mg)<br>* parturients will receive oral Erythromycin (400mg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Gastric volume | (mL) based on the antral CSA in the RLD (CSARLD) by gastric ultrasonic after administration of the study drug. | UP TO 24 HOURE | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration for performing the ultrasound scanning | minute | up to 2 hours |