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

This study is currently recruiting participants.
Verified November 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01734161
First received: November 20, 2012
Last updated: November 26, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734161

Contacts
Contact: Klaus Kjaer, MD 212-746-2781 klk9001@med.cornell.edu
Contact: Kelli O'Connell, BA 212-746-2428 keo2008@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York City, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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
Vomiting
Postoperative Nausea and 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 April 21, 2014