Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Study Overview
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Brief Summary
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The purpose of this study is to clarify whether or not a low-dose propofol infusion can effectively prevent postoperative nausea and vomiting (PONV) in patients who have a documented history of PONV and/or motion sickness.

Detailed Description
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Propofol is administered as both low dose and as sole anesthetic in patients with history of PONV and/or motion sickness. But efficacy of one dose over the other is not studied. This study plans to clarify if propofol in low dose is as effective as its administration as sole anesthetic in patients with history of PONV and/or motion sickness

Official Title
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Prevention of Post-Operative Nausea and Vomiting With Propofol Infusion

Conditions
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Post-operative Nausea and Vomiting

Intervention / Treatment
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* Drug: Propofol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing general anesthesia for elective surgery Documented history of Patient's self-disclosure of PONV and/or motion sickness during pre-anesthesia discussions No documented allergy/adverse reaction to propofol English speaking At least 18 years of age Exclusion Criteria: Any anti-nausea medication taken within 24 hours prior to surgery Unable to provide consent independently Allergy or adverse reaction to propofol Emergency surgery

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Low-dose propofol infusion at 25 mcg/kg/min | Drug: Propofol<br>* Propofol is administered starting at surgery induction and ending at skin closure<br>* Other names: 2,6 di-isopropylphenol;|
| Placebo Comparator: Placebo<br>Same volume of 0.9% normal saline as the study group | Other: Placebo<br>* Placebo is administered starting at surgery induction and ending at skin closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea (urge to vomit) episodes | Number of self-reported nausea episodes | 24 hours | 
| Retching (labored, spasmodic, rhythmic contractions of respiratory muscles without expulsion of gastric contents) episodes | Number of self-reported retching episodes | 24 hours | 
| Vomiting (forceful expulsion of gastric contents) episodes | Number of self-reported vomiting episodes | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choice of antiemetic- Dexamethasone | medication administered. | 24 hours | 
| Number of times dexamethasone administered | frequency of administration | 24 hours | 
| Choice of antiemetic- Ondansetron | medication administered. | 24 hours | 
| Number of times ondansetron administered | frequency of administration | 24 hours | 
| Choice of antiemetic- Promethazine | medication administered | 24 hours | 
| Number of times promethazine administered | frequency of administration | 24 hours | 
| Choice of antiemetic- metoclopramide | medication administered | 24 hours | 
| Number of times metoclopramide administered | frequency of administration | 24 hours | 
| Choice of antiemetic- Prochlorperazine | medication administered | 24 hours | 
| Number of times prochlorperazine administered | frequency of administration | 24 hours | 
| Choice of antiemetic- Droperidol | medication administered | 24 hours | 
| Number of times droperidol administered | frequency of administration | 24 hours | 
| Choice of antiemetic- scopolamine | medication administered | 24 hours | 
| Number of times scopolamine administered | frequency of administration | 24 hours | 
| Choice of antiemetic-diphenhydramine | medication administered | 24 hours | 
| Number of times diphenhydramine administered | frequency of administration | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Operative Nausea, Post-Operative Vomiting, propofol, motion sickness