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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-08-31

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.

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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.

Conditions

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexamethasone

One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

8mg IV dexamethesone given

Placebo

One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subjects randomized to placebo receive 50cc normal saline

Interventions

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Dexamethasone

8mg IV dexamethesone given

Intervention Type DRUG

Placebo

Subjects randomized to placebo receive 50cc normal saline

Intervention Type DRUG

Other Intervention Names

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Decadron 50 ml 0.9% saline

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes