Evaluating the Effectiveness of Ondansetron Versus Dexamethasone Versus Placebo for the Control of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are: Which drug is the best at reducing the incidence of intraoperative nausea and vomiting. Which drug is the best at reducing intraoperative pain. Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C. A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded. Data collected from the three groups will be analyzed using SPSS software.

Official Title
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Comparing the Efficacy of Ondansetron, Dexamethasone, and Placebo for the Reduction of Intraoperative Nausea and Vomiting in Patients Undergoing Lower-segment Caesarean Section Under Spinal Anesthesia

Conditions
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Caesarean Section, Spinal Anesthesia

Intervention / Treatment
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* Drug: Ondansetron 8mg
* Drug: Dexamethasone 8mg
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 20 but less than 35 years old Given informed consent No contraindication to spinal anesthesia ASA I or II Exclusion Criteria: Age less than 20 or more than 35 years old Non-consenting Contraindication to spinal anesthesia ASA III or IV

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>Patients given Ondansetron (8mg) | Drug: Ondansetron 8mg<br>* 8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia<br>|
| Experimental: Dexamethasone<br>Patients given Dexamethasone (8mg) | Drug: Dexamethasone 8mg<br>* 8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia<br>|
| Placebo Comparator: Placebo<br> | Drug: Normal saline<br>* Normal saline will be given IV stat to the group after induction of spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative nausea | Measured by an 11-point numeric rating scale | 20 minutes after initiation of procedure | 
| Intraoperative vomiting | Number of episodes of vomiting throughout the procedure | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative pain | Measured by an 11-point numeric rating scale | 20 minutes after the initiation of procedure |