Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

Study Overview
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Brief Summary
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Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus. Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV). Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.

Detailed Description
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A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.

Official Title
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A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section

Conditions
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Pruritus, Cesarean Section

Intervention / Treatment
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* Drug: Ondansetron (Zofran)
* Drug: Dexamethasone (Decadron)
* Other: Spinal anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology physical status 1 and 2 Scheduled for elective c-section surgery under spinal anesthesia Exclusion Criteria: Patients with cardiac and psychological problems Patients who take sedatives or narcotics Patient who have allergy to study drugs

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron<br> | Drug: Ondansetron (Zofran)<br>* Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia<br>Other: Spinal anesthesia<br>* Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)<br>|
| Experimental: Ondansetron+ dexamethasone<br> | Drug: Ondansetron (Zofran)<br>* Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia<br>Drug: Dexamethasone (Decadron)<br>* Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia<br>Other: Spinal anesthesia<br>* Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pruritus assessed through questionnaire |  | 24 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative nausea and vomiting assessed through questionnaire |  | 24 hours postoperatively |