Effects of Ondansetron Dose and Timing on Post-operative Nausea and Vomiting

Study Overview
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Brief Summary
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The aim is to evaluate the effectiveness of three different regimens of prophylactic ondansetron on the incidence and severity of post-operative nausea and vomiting.

Detailed Description
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Patients will be randomize to one of three arms: 4mg ondansetron pre-emergence, 8 mg ondansetron pre-emergence, or 4mg ondansetron pre-incision followed by 4mg ondansetron pre-emergence. Primary outcome will be incidence of PONV in the PACU prior to discharge.

Official Title
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Effects of Ondansetron Dose and Timing on Rates of Post-operative Nausea and Vomiting

Conditions
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Post-operative Nausea and Vomiting

Intervention / Treatment
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* Drug: Ondansetron 4 MG
* Drug: Ondansetron 8mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia Exclusion Criteria: Patients with allergies or contraindications to study medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Ondansetron 4mg Pre-emergence<br> | Drug: Ondansetron 4 MG<br>* dose as per arm selection<br>|
| Experimental: Ondansetron 8mg Pre-emergence<br> | Drug: Ondansetron 8mg<br>* dose as per arm selection<br>|
| Experimental: Ondansetron Pre-Incision and Pre-emergence<br>4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence | Drug: Ondansetron 4 MG<br>* dose as per arm selection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea Scale | Nausea Scale - full scale from 1-10, with higher score indicating more symptom of nausea | average of 4 hours in PACU and POD1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Episodes of Vomiting in the PACU | Number of participants with episodes of vomiting in the Post Anesthesia Care Unit | average of 4 hours | 
| Number of Participants With Symptoms on POD 1 | Number of participants with symptom presence of nausea or vomiting or headache on post-operative day one | Day 1 | 
| Number of Participants Who Needed Rescue Anti-emetics | Number participants who needed rescue anti-emetics, i.e,, additional treatments needed to control nausea or vomiting in the PACU | average of 4 hours | 
| Total Anesthesia Time |  | intraoperative, up to 3.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ambulatory surgery, post-operative nausea and vomiting, general anesthesia