A Phase 4 interventional study of Dexamethasone and Placebo in Postoperative Nausea and Vomiting, sponsored by Weill Medical College of Cornell University. Completed at 1 site in United States. Open to female participants aged 18 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-15.
Sponsored by Weill Medical College of Cornell University · Phase 4, Interventional, and Prevention
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.
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.
629 studies on the registry are indexed under Postoperative Nausea and Vomiting; 113 are open to participants now.
This study's enrollment of 122 is close to the median of 111 across 525 interventional studies indexed under Postoperative Nausea and Vomiting.
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Exclusion Criteria:
One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Drug: Dexamethasone
One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Drug: Placebo
8mg IV dexamethesone given
Also known as: Decadron
Subjects randomized to placebo receive 50cc normal saline
Also known as: 50 ml 0.9% saline
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
Time frame: 48 hours
| Milestone | Dexamethasone | Placebo |
|---|---|---|
| Started | 61 | 61 |
| Completed | 55 | 53 |
| Not completed | 6 | 8 |
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
| Participants | Dexamethasone | Placebo |
|---|---|---|
| Incidence of Post-operative Nausea and/or Vomiting | 29 | 24 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone | 0/55 (0%) | 0/55 (0%) | 7/55 (12.7%) |
| Placebo | 0/53 (0%) | 0/53 (0%) | 3/53 (5.7%) |
| Event | Dexamethasone | Placebo |
|---|---|---|
| HypertensionVascular disorders | 1/55 | 3/53 |
| low body temperatureGeneral disorders | 2/55 | 0/53 |
| incision site bleedingSurgical and medical procedures | 1/55 | 0/53 |
| post-op shiveringGeneral disorders | 1/55 | 0/53 |
| TachycardiaCardiac disorders | 1/55 | 0/53 |
| Transfusion RequiredVascular disorders | 1/55 | 0/53 |
| Age, Continuous(years) | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Mean | 35.2 ± 5.2 | 35.7 ± 3.7 | 35.5 ± 4.5 |
| Sex: Female, Male(Participants) | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Female | 55 | 53 | 108 |
| Male | 0 | 0 | 0 |
Plan to share: No — No plan to share IPD
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Studies of the drug tested here: Dexamethasone
Postoperative Nausea and Vomiting →
Weill Medical College of Cornell University →