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

Ochsner Health System

Status: Withdrawn

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: transdermal nicotine patch; Drug: placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT00775749

PONV

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.

Treatment:

Drug: transdermal nicotine patch

2

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo patch