Dexamethasone for the Prevention of Post-operative Nausea and Vomiting in Patients Undergoing Cesarean Sections
Recruitment status was Recruiting
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.
Postoperative Nausea and Vomiting
|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|
- 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.
- 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.
|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)|
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.
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.
Other Name: 50 ml 0.9% saline
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734161
|Contact: Klaus Kjaer, MDfirstname.lastname@example.org|
|Contact: Kelli O'Connell, BAemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York City, New York, United States, 10065|
|Principal Investigator:||Klaus Kjaer, MD||Weill Medical College of Cornell University|