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

Information source: Weill Medical College of Cornell University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: Dexamethasone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Weill Medical College of Cornell University

Official(s) and/or principal investigator(s):
Klaus Kjaer, MD, Principal Investigator, Affiliation: Weill Medical College of Cornell University

Overall contact:
Klaus Kjaer, MD, Phone: 212-746-2781, Email: klk9001@med.cornell.edu

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Incidence of post-operative nausea and/or vomiting

Total consumption of anti-emetic medications

Secondary outcome:

Subject's self-reported visual analog scale (VAS) pain scores

Overall satisfaction

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Klaus Kjaer, MD, Phone: 212-746-2781, Email: klk9001@med.cornell.edu

Weill Cornell Medical College, New York City, New York 10065, United States; Recruiting
Additional Information

Nausea and Vomiting

Drug information for Dexamethasone

Related publications:

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.

Cardoso MM, Leite AO, Santos EA, Gozzani JL, Mathias LA. Effect of dexamethasone on prevention of postoperative nausea, vomiting and pain after caesarean section: a randomised, placebo-controlled, double-blind trial. Eur J Anaesthesiol. 2013 Mar;30(3):102-5. doi: 10.1097/EJA.0b013e328356676b.

Hamzei A, Basiri-Moghadam M, Pasban-Noghabi S. Effect of dexamethasone on incidence of headache after spinal anesthesia in cesarean section. A single blind randomized controlled trial. Saudi Med J. 2012 Sep;33(9):948-53.

Starting date: November 2012
Last updated: November 26, 2012

Page last updated: August 20, 2015

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