Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postoperative Nausea and Vomiting |
Drug: Dexamethasone Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
- Incidence of post-operative nausea and/or vomiting [ Time Frame: 48 hours ] [ Designated as safety issue: No ]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
- Total consumption of anti-emetic medications [ Time Frame: 48 hours ] [ Designated as safety issue: No ]The subjects's use of anti-emetics will be recorded intraoperatively, upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours after surgery.
- Subject's self-reported visual analog scale (VAS) pain scores [ Time Frame: 48 hours ] [ Designated as safety issue: No ]The subjects's self reported visual analog scale (VAS) pain scores will be recorded upon arrival to the PACU and at 1, 3, 6, 24, and 48 hours following surgery
- Overall satisfaction [ Time Frame: 48 hours ] [ Designated as safety issue: No ]The subject's overall satisfaction will be recorded upon arrival to the PACU, and at 1, 3, 6, 24, and 48 hours after surgery.
| Estimated Enrollment: | 108 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Dexamethasone
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
|
Drug: Dexamethasone
Other Name: Decadron
|
|
Placebo Comparator: Placebo
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
|
Drug: Placebo
Other Name: 50 ml 0.9% saline
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women aged 18-40 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
Contacts and Locations| Contact: Klaus Kjaer, MD | 212-746-2781 | klk9001@med.cornell.edu |
| Contact: Kelli O'Connell, BA | 212-746-2428 | keo2008@med.cornell.edu |
| United States, New York | |
| Weill Cornell Medical College | Recruiting |
| New York City, New York, United States, 10065 | |
| Principal Investigator: | Klaus Kjaer, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
Publications:
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01734161 History of Changes |
| Other Study ID Numbers: | 1207012632 |
| Study First Received: | November 20, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Weill Medical College of Cornell University:
|
cesarean section nausea vomiting |
dexamethasone postoperative nausea and vomiting antiemetics |
Additional relevant MeSH terms:
|
Nausea Postoperative Nausea and Vomiting Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013