Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

Study Overview
=================
Brief Summary
-----------------
Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. The present study explored the research question whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA

Detailed Description
-----------------
Since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. Nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). The administration of intravenous anaesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anaesthesia. The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml and its pH falls below 2.5. However, the risk of aspiration significantly decreases in fasted outpatients. Since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis is not recommended anymore. the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p<0.05). The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls (6.9ml versus 15.3ml, p<0.05). Hong (2006) further showed that the percentage of individuals with high-risk gastric volume (>25 ml) and low pH (<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p<0.05) .

Official Title
-----------------
the Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume and Antral Cross Sectional Area in Patients Awaiting for Caesarean Section :a Randomized Double Blind Study.

Conditions
-----------------
Aspiration Prophylaxis

Intervention / Treatment
-----------------
* Diagnostic Test: Abdominal ultrasound evaluation of antral area


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate. Exclusion Criteria: a neurological and psychological disorders renal or hepatic diseases chronic gastroesophageal reflux diseases refusal to consent

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 38 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention group:<br>Patients (n=35) fasting for 8 hours and received 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. | Diagnostic Test: Abdominal ultrasound evaluation of antral area<br>* ultrasound assessment of antral cross sectional area<br>* Other names: Nausea and vomiting episodes;|
| Control group:<br>Patients (n=35) fasting for 8 hours and received intravenous 10 mL saline 0.9% as placebo | Diagnostic Test: Abdominal ultrasound evaluation of antral area<br>* ultrasound assessment of antral cross sectional area<br>* Other names: Nausea and vomiting episodes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of S intravenous metoclopramide prophylaxis on gastric volume | antral cross section will be measured using ultrasound machine before and after metoclopramide injection | 2 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metoclopramide, cesarean section, ultrasound, gastric volume