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Dexamethasone vs Ondansetron After Cesarean Delivery

Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05692245
Enrollment
100
Registered
2023-01-20
Start date
2023-03-30
Completion date
2024-04-30
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Nausea and Vomiting, Postoperative

Brief summary

The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are: • Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.

Detailed description

Cesarean delivery is the most common surgical procedure performed in the United States, with approximately 1.2 million cesarean deliveries performed in 2020.(1) Cesarean delivery is preferentially performed under neuraxial anesthesia (spinal or epidural anesthesia) to allow mothers to be awake during the delivery of their child and to improve maternal safety. Despite the routine use of neuraxial techniques for most cesarean deliveries in the United States, many patients experience nausea and/or vomiting either during surgery (intraoperative nausea and vomiting, IONV) or after surgery (postoperative nausea and vomiting, PONV). PONV has traditionally been associated with female gender, history of motion sickness, nonsmoking status, and opioid use.(2) Other authors have shown increased PONV risk with younger age, type of surgery, and general anesthesia as opposed to regional or neuraxial anesthesia.(3,4) Intrathecal opioids, are the gold standard for pain relief after cesarean delivery, and are part of the Society for Obstetric Anesthesia and Perinatology's (SOAP) Early Recover After Cesarean (ERAC) guideline. However, these medications have been implicated in increased rates of PONV.(5) Given the prevalence of cesarean delivery and the importance of maternal well-being, prophylaxis of nausea and vomiting remains an important issue to address. Medications from multiple classes are commonly administered to prevent and treat PONV after cesarean delivery. These include 5-HT3 antagonists, dopaminergic antagonists, corticosteroids, antihistamines, and anticholinergics. Ondansetron, a 5HT3 antagonist, and dexamethasone, a corticosteroid, are among the most commonly administered medications due to their efficacy and long track record of safety during pregnancy. Indeed, the SOAP ERAC guideline recommends that at least two agents from different classes be administered perioperatively to decrease the rates of IONV and PONV.(6) They further suggest metoclopramide for IONV prophylaxis, ondansetron or dexamethasone for PONV prophylaxis. The safety and efficacy of ondansetron and dexamethasone are further supported by a 2021 Cochrane Systematic review analyzing medical prophylaxis against IONV and PONV in cesarean delivery.(6) Both ondansetron and dexamethasone decreased postoperative nausea (Ond: RR 0.45; 10 RCT, 1340 total subjects; Dex: RR 0.59; 6 studies, 733 women) and vomiting rates (Ond: RR 0.47, 10 studies, 1450 women; Dex: RR 0.68; 7 RCT, 793 women). No adverse events from 5HT3 blocking agents or corticosteroids were identified. Dexamethasone is intriguing as a first-line agent for cesarean delivery since it may have the added benefit of improved pain control and/or decreased postoperative opioid requirement. Several studies have addressed the role of dexamethasone in pain management. A 2008 study by Jaafarpour et al.(8) found a decrease in composite rates of nausea and vomiting, as well reduction of \ 1 point on the VAS pain scale for 24 hours following surgery. Data from other studies have been mixed (9, 10, 11). In conclusion, there is a gap in knowledge in defining the optimal first-line antiemetic for prophylaxis of PONV in patients undergoing cesarean delivery. The goal of this study is to evaluate the effectiveness of ondansetron vs. dexamethasone on PONV rates and postoperative pain control.

Interventions

DRUGOndansetron

Administered Medication

DRUGDexamethasone

Administered Medication

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Randomized assignment maintained in a sealed envelop. Study medication provided by a independent party. Investigators remain blinded until completion of analysis.

Intervention model description

Randomized, Double-blind

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Healthy women (ASA 2) * Between 18 and 45 years old * Singleton term pregnancies * Scheduled or non-labor cesarean delivery * Neuraxial (spinal or combined-spinal epidural) anesthesia

Exclusion criteria

* Refusal to participate * Known allergy or contraindication to any medication used in the study * Significant medical or obstetrical disease (ASA ≥ 3) * Antiemetic use within 24 hours preceding cesarean delivery * Insulin dependent diabetes * Hyperemesis gravidarum or chronic antiemetic use * History of daily or near-daily steroid use during pregnancy * Opioid use disorder or other chronic pain syndrome * Opioid use during pregnancy * Use of antipruritus medication, pruritic urticarial papules of pregnancy, or cholestasis of pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Medications Received24 hoursTotal number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain

Secondary

MeasureTime frameDescription
Severity of Nausea24 hoursVisual analogue score for Nausea scored on a 10 centimeter line with "No nausea" on the left and "Worst possible nausea" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater nausea.
Severity of Pain24 hoursVisual analogue score for Pain scored on a 10 centimeter line with "No pain" on the left and "Worst possible pain" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater pain.

Countries

United States

Baseline characteristics

Characteristic
Age, Continuous35.4 years
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
47 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
6 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
Race (NIH/OMB)
White
36 Participants
Sex: Female, Male
Female
48 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 47
other
Total, other adverse events
0 / 480 / 47
serious
Total, serious adverse events
0 / 480 / 47

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026