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

April 10, 2023 updated by: Stuart Hart, Ochsner Health System

Transdermal Nicotine in Female Patients at High Risk for PONV

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.
Drug: transdermal 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.
Other Names:
  • Nicoderm CQ Step 3
Placebo Comparator: 2
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
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.
Other Names:
  • Tegaderm patch

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ochsner Health System

Investigators

  • Principal Investigator: Stuart R Hart, M.D., Ochsner Health Systems
  • Study Director: Heather S Porter, Ochsner Health Systems

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Actual)

April 11, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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