Postoperative Nausea and Vomiting
Conditions
Keywords
cesarean section, nausea, vomiting, dexamethasone, postoperative nausea and vomiting, antiemetics
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.
Interventions
DRUGDexamethasone
8mg IV dexamethesone given
DRUGPlacebo
Subjects randomized to placebo receive 50cc normal saline
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 46 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-operative Nausea and/or Vomiting | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.
Dexamethasone: 8mg IV dexamethesone given | 55 |
| Placebo One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.
Placebo: Subjects randomized to placebo receive 50cc normal saline | 53 |
| Total | 108 |
Baseline characteristics
| Characteristic | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.2 years STANDARD_DEVIATION 5.2 | 35.7 years STANDARD_DEVIATION 3.7 | 35.5 years STANDARD_DEVIATION 4.5 |
| Sex: Female, Male Female | 55 Participants | 53 Participants | 108 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 53 |
| other Total, other adverse events | 7 / 55 | 3 / 53 |
| serious Total, serious adverse events | 0 / 55 | 0 / 53 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Post-operative Nausea and/or Vomiting | 29 Participants |
| Placebo | Incidence of Post-operative Nausea and/or Vomiting | 24 Participants |