Postoperative Nausea and Vomiting
Conditions
Keywords
post operative nausea and vomiting, gynecological surgery, outpatient surgery, nicotine patch, laparoscopic surgery
Brief summary
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
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.
Interventions
DRUGtransdermal nicotine patch
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.
DRUGplacebo patch
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.
Sponsors
Ochsner Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
United States
Outcome results
None listed