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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring cesarean section, nausea, vomiting, dexamethasone, postoperative nausea and vomiting, antiemetics

Eligibility Criteria

18 Years - 46 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women aged 18-46 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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of Post-operative Nausea and/or Vomiting
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

Secondary Outcome Measures

Full Information

First Posted
November 20, 2012
Last Updated
October 4, 2019
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01734161
Brief Title
Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections
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 Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
cesarean section, nausea, vomiting, dexamethasone, postoperative nausea and vomiting, antiemetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
8mg IV dexamethesone given
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
50 ml 0.9% saline
Intervention Description
Subjects randomized to placebo receive 50cc normal saline
Primary Outcome Measure Information:
Title
Incidence of Post-operative Nausea and/or Vomiting
Description
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
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 18-46 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Kjaer, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Citations:
PubMed Identifier
22344239
Citation
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.
Results Reference
background
PubMed Identifier
23022704
Citation
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.
Results Reference
background
PubMed Identifier
22964805
Citation
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.
Results Reference
background
PubMed Identifier
31989472
Citation
Selzer A, Pryor KO, Tangel V, O'Connell K, Kjaer K. The effect of intravenous dexamethasone on postoperative nausea and vomiting after Cesarean delivery with intrathecal morphine: a randomized-controlled trial. Can J Anaesth. 2020 Jul;67(7):817-826. doi: 10.1007/s12630-020-01582-y. Epub 2020 Jan 27.
Results Reference
derived
Links:
URL
http://www.nlm.nih.gov/medlineplus/nauseaandvomiting.html
Description
Nausea and Vomiting
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000050022&QV1=DEXAMETHASONE
Description
Drug information for Dexamethasone

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

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