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Dexamethasone vs Ondansetron After Cesarean Delivery

Primary Purpose

Nausea and Vomiting, Postoperative, Cesarean Section Complications, Spinal Epidrual

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ondansetron
Dexamethasone
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea and Vomiting, Postoperative

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ondansetron

Dexamethasone

Arm Description

ondansetron 4 mg intravenous, given once after initiation of anesthesia

dexamethasone 8 mg intravenous, given once after initiation of anesthesia

Outcomes

Primary Outcome Measures

Severity of Nausea
Visual analogue score for Nausea

Secondary Outcome Measures

Severity of Vomiting
Number of times subject vomits
Severity of Pain
Visual analogue score for Pain

Full Information

First Posted
January 11, 2023
Last Updated
January 11, 2023
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05692245
Brief Title
Dexamethasone vs Ondansetron After Cesarean Delivery
Official Title
Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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. Our goal is to evaluate the effectiveness of ondansetron vs. dexamethasone on PONV rates and postoperative pain control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Postoperative, Cesarean Section Complications, Spinal Epidrual

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-blind
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomized assignment maintained in a sealed envelop. Study medication provided by a independent party. Investigators remain blinded until completion of analysis.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Active Comparator
Arm Description
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
Administered Medication
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Administered Medication
Primary Outcome Measure Information:
Title
Severity of Nausea
Description
Visual analogue score for Nausea
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Severity of Vomiting
Description
Number of times subject vomits
Time Frame
24 hours
Title
Severity of Pain
Description
Visual analogue score for Pain
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexamethasone vs Ondansetron After Cesarean Delivery

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