Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections

Study Overview
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Brief Summary
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Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Detailed Description
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Women having cesarean sections commonly experience post-operative nausea and vomiting (PONV). This can be partly attributed to the long acting morphine (duramorph) given in the anesthetic (either through the epidural or in the spinal anesthetic). Intravenous dexamethasone is a widely used steroid medication with a well-established safety profile which is the standard of care for the prevention of PONV for general anesthesia in both adult and pediatric surgical patients. Many studies have shown that when intravenous dexamethasone is administered before duramorph in the epidural, the incidence of nausea and vomiting following cesarean section is significantly reduced. However, when patients receive intravenous dexamethasone after duramorph in a spinal anesthetic, it does not reduce the incidence of nausea and vomiting. There are not any published studies where dexamethasone was administered before a spinal anesthetic. The investigators believe that if dexamethasone is given intravenously before duramorph in a spinal anesthetic it may reduce the incidence of nausea and vomiting. Patients who present for scheduled (non-emergent) cesarean section will be given either intravenous dexamethasone or placebo prior to receiving a duramorph containing spinal anesthetic. The investigators will then compare the incidence of nausea and vomiting and the use of rescue anti-nausea medications in both groups. Our hypothesis is that patients receiving dexamethasone prior to duramorph containing spinal anesthesia for cesarean section will have a significantly lower incidence and severity of PONV at 0, 1, 3, 6, and 24 hours following surgery.

Official Title
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A Prospective, Randomized, Double-Blinded Study to Evaluate the Efficacy of Intravenous Dexamethasone for Nausea Prophylaxis Prior to Duramorph and Bupivacaine Spinal Anesthesia for Scheduled Cesarean Section

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study Exclusion Criteria: allergy to dexamethasone or morphine history of gastrointestinal disease history of severe nausea during pregnancy (hyperemesis gravidarum) use of anti-emetic in the past 24 hours history of gestational diabetes or diabetes mellitus history of hypertension prior to or during pregnancy presence of non-viable fetus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Dexamethasone<br>One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes. | Drug: Dexamethasone<br>* 8mg IV dexamethesone given<br>* Other names: Decadron;|
| Placebo Comparator: Placebo<br>One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes. | Drug: Placebo<br>* Subjects randomized to placebo receive 50cc normal saline<br>* Other names: 50 ml 0.9% saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Post-operative Nausea and/or Vomiting | The patient's self report of nausea and incidence of vomiting will be recorded intra-operatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, nausea, vomiting, dexamethasone, postoperative nausea and vomiting, antiemetics