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

Not Applicable

Withdrawn

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: placebo patch; Drug: transdermal nicotine patch

• Registration Number: NCT00775749
• Lead Sponsor: Ochsner Health System

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.

Study Timeline

• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Study Start: 2009-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo patch	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.
1	transdermal nicotine patch	The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States