Clinical trial NCT00775749: Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)
Official title: Transdermal Nicotine in Female Patients at High Risk for PONV
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: post operative nausea and vomiting
gynecological surgery
outpatient surgery
nicotine patch
laparoscopic surgery
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2008-10-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting.
timeFrame: The outcome measure will be assessed within 24 hours after the application of the patch.
Secondary outcomes:
measure: The secondary outcome is to assess how many episodes of post-operative nausea and/or vomiting the patient experiences.
timeFrame: The outcome measure will be assessed within 24 hours of the application of the patch.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
Study officials:
affiliation: Ochsner Health Systems
name: Stuart R Hart, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ochsner Health Systems
name: Heather S Porter
role: STUDY_DIRECTOR
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