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

NCT01734161 | Completed Phase 4 Results

• 1 other identifier: 1207012632
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

cesarean section; nausea; vomiting; dexamethasone; postoperative nausea and vomiting; antiemetics

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Dexamethasone DRUG

8mg IV dexamethesone given

Also known as: Decadron

Dexamethasone

Placebo DRUG

Subjects randomized to placebo receive 50cc normal saline

Also known as: 50 ml 0.9% saline

Placebo

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-46 presenting for scheduled primary or repeat cesarean sections and have consented to study

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Related Publications (4)

• 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.

  PMID: 22344239 BACKGROUND

• 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.

  PMID: 23022704 BACKGROUND

• 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.

  PMID: 22964805 BACKGROUND

• 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.

  PMID: 31989472 DERIVED

Related Links

• Nausea and Vomiting
• Drug information for Dexamethasone

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Nausea; Vomiting

Interventions

Dexamethasone; Calcium Dobesilate; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Klaus Kjaer, MD
• Organization: Weill Cornell Medicine

klk9001@med.cornell.edu

(212) 746-2953

Study Officials

• Klaus Kjaer, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: August 1, 2015
• Last Updated: October 15, 2019
• Results First Posted: April 12, 2017

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)