Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)

Study Overview
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Brief Summary
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The purpose of this study is to see if the nicotine patch reduces post operative nausea and/or vomiting (PONV) among non-smoking patients who are at high risk of PONV.

Detailed Description
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There are certain known risk factors for post-operative nausea and/or vomiting: the use of opioids during surgery, female gender, laparoscopic surgery, gynecologic surgery, strabismus repair, the use of a general anesthetic, obesity, and non-smoker. Patients with four or more of these risk factors have an 80% occurrence rate of post-operative nausea and/or vomiting and are classified as high risk. It has been shown that those who use tobacco have about a 50% reduction in post-operative nausea and/or vomiting.

Official Title
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Transdermal Nicotine in Female Patients at High Risk for PONV

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Drug: transdermal nicotine patch
* Drug: placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-65 female health patient or acute illness undergoing outpatient-type general surgery, especially those associated with increased incidence of post-operative nausea and/or vomiting such as gynecological procedures undergoing general anesthesia for the surgery receiving opioids during surgery non-smokers Exclusion Criteria: history of any heart condition history of uncontrolled hypertension, or presence of any condition that could be made drastically worse by an increase in blood pressure history of an aneurysm active tobacco use within the past five years works or lives in the presence of cigarette smoke pregnant mentally ill prisoners history of allergic reaction to nicotine or to adhesive patches history of allergic reaction to propofol, versed, fentanyl, zofran, decadron, and reglan

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: 1<br>The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours. | Drug: transdermal nicotine patch<br>* The 7 mg transdermal nicotine patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.<br>* Other names: Nicoderm CQ Step 3;|
| Placebo Comparator: 2<br>The placebo patch has no active ingredients and the same inactive ingredients as the nicotine patch. It will be administered the same fashion as the nicotine patch. | Drug: placebo patch<br>* The placebo patch will be applied to the right upper back prior to surgery. It will be covered with an opaque bandage to minimize inadvertent removal and conceal which patch has been placed.<br>* Other names: Tegaderm patch;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting. |  | The outcome measure will be assessed within 24 hours after the application of the patch. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is to assess how many episodes of post-operative nausea and/or vomiting the patient experiences. |  | The outcome measure will be assessed within 24 hours of the application of the patch. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post operative nausea and vomiting, gynecological surgery, outpatient surgery, nicotine patch, laparoscopic surgery