Prevention of Intraoperative Nausea and Vomiting During Cesarean Section

Study Overview
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Brief Summary
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The study investigates the incidence of intraoperative nausea and vomiting under spinal anesthesia using a phenylephrine infusion with and without prophylactic antiemetics.

Official Title
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The Effect of Adding Metoclopramide and Ondansetron to a Prophylactic Phenylephrine Infusion for the Management of Nausea and Vomiting Associated With Spinal Anesthesia for Cesarean Section

Conditions
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Cesarean Delivery

Intervention / Treatment
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* Drug: Metoclopramide
* Drug: Phenylephrine infusion
* Drug: Combination Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking ASA I-II non-laboring women with single gestations ≥36 weeks Scheduled or unscheduled cesarean delivery under spinal anesthesia Height: 5 feet-5 feet 11 in. Exclusion Criteria: Laboring women needing an emergency cesarean delivery Subjects less than 18 years of age Receipt of a drug with antiemetic properties in the 24 hours prior to cesarean section Allergy to ondansetron, or metoclopramide Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria. Severe Cardiac disease in pregnancy with marked functional limitations Diabetes type I Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants Morbid obesity (body mass index (BMI)>45) Inclusion in another anesthetic study involving drug administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Metoclopramide<br>Prophylaxis with metoclopramide and phenylephrine infusion. | Drug: Metoclopramide<br>* Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion<br>|
| Placebo Comparator: Phenylephrine infusion<br>Prophylactic phenylephrine infusion and placebo antiemetics | Drug: Phenylephrine infusion<br>* Prophylactic phenylephrine infusion after spinal and placebo antiemetics<br>|
| Active Comparator: Combination Group<br>Metoclopramide and Ondansetron prophylaxis with phenylephrine infusion | Drug: Combination Group<br>* Metoclopramide and ondansetron prophylaxis with phenylephrine infusion<br>* Other names: Metoclopramide and ondansetron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Nausea and Vomiting | Comparison of intraoperative nausea and vomiting between the 3 groups. | Intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Nausea and Vomiting (PONV) |  | 0-2h, 2-6h, 6-24h | 
| Pruritus |  | 0-24 hrs | 
| Satisfaction | 1=very satisfied, 2=somewhat satisfied, 3= neither satisfied nor dissatisfied, 4=somewhat dissatisfied, 5= very dissatisfied. Number of very satisfied subjects posted. | 24 h | 
| Maternal Hemodynamics | The number of patients with systolic blood pressure decrease to less than 20 % of baseline intraoperatively | Intraoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting