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

Postoperative Nausea and Vomiting research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Postoperative Nausea and Vomiting

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Dexamethasone8mg IV dexamethesone given

Drug:PlaceboSubjects randomized to placebo receive 50cc normal saline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: November 2012

Completed Date: August 2015

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Incidence of Post-operative Nausea and/or Vomiting

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Klaus Kjaer, MD

Lead Sponsor: Weill Medical College of Cornell University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01734161

Allen TK, Jones CA, Habib AS. Dexamethasone for the prophylaxis of postoperative nausea and vomiting associated with neuraxial morphine administration: a systematic review and meta-analysis. Anesth Analg. 2012 Apr;114(4):813-22. doi: 10.1213/ANE.0b013e318247f628. Epub 2012 Feb 17. Review.

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