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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01734161
First Posted: November 27, 2012
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
  Purpose
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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


Enrollment: 122
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: September 2014 (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
8mg IV dexamethesone given
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
Subjects randomized to placebo receive 50cc normal saline
Other Name: 50 ml 0.9% saline

Detailed Description:
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734161


Locations
United States, New York
Weill Cornell Medical College
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
First Submitted: November 20, 2012
First Posted: November 27, 2012
Results First Submitted: February 28, 2017
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD

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
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action