Gastric Volumes by US in Term Parturients Undergoing CS With and Without Metoclopramide

Study Overview
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Brief Summary
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Our objective is to compare gastric volumes (mL) between women who receive metoclopramide versus placebo prior to scheduled cesarean delivery in appropriately fasted patients. If metoclopramide is found not to reduce gastric volumes this would inform future practice guidelines for obstetric anesthesia, which currently recommends metoclopramide administration prior to cesarean deliveries. We hypothesize that metoclopramide given to women with appropriate fasting prior to cesarean delivery does not result in any clinically significant reduction in gastric volume (mL) and therefore does not provide any additional benefit for aspiration prophylaxis but may expose patients to unnecessary side effects. A secondary objective will be to evaluate if gastric volume is a significant predictor of intraoperative nausea and vomiting.

Official Title
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Comparison of Gastric Volumes by Gastric Ultrasound in Term Parturients Undergoing Scheduled Elective Cesarean Delivery With and Without Metoclopramide

Conditions
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Pregnancy, Cesarean Section, Aspiration

Intervention / Treatment
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* Drug: Study drug metoclopramide
* Drug: Study drug placebo administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy (ASA Physical Status 2) Age >18 years old Non-obese (BMI <40 kg/m2) Age >18 years Term (>37 week) Non-laboring parturient Single gestation Scheduled for a cesarean delivery and NPO Exclusion Criteria: Systemic disease such as diabetes mellitus (type 1 or 2) Multiple gestation Abnormality of upper GI tract History of GI tract related surgical procedures Use of gastric motility medications Active labor Renal impairment (creatinine >2) Non-English speaking Cognitively impaired History of QT prolongation Use of general anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Interventional Model Description: Randomized controlled blinded study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Study Drug Metoclopramide<br>Intravenous administration of 10 mg metoclopramide | Drug: Study drug metoclopramide<br>* Intravenous administration of 4 mg metoclopramide<br>|
| Placebo Comparator: Group 2 Study Drug Placebo<br>Intravenous administration of sterile normal saline | Drug: Study drug placebo administration<br>* Intravenous administration of placebo (sterile normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastric volume (mL) | Change in gastric volume (mL) determined by ultrasound before and 30 minutes after administration of study drug | 30 minutes after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence (number of events) of nausea and vomiting | Number of episodes (events) of intraoperative nausea and vomiting during cesarean delivery and post-operative nausea and vomiting after cesarean delivery (correlated to metoclopramide administration and gastric volume) | 24 hours | 
| Adverse events | Number of adverse events (akathisia, dystonia, abdominal cramping, extrapyramidal symptoms) experienced between the two study groups. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Pregnancy, Gastric Volume, Ultrasound Measurement, Aspiration Prevention