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

• Sponsor: Ochsner Health System (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00775749
• Collaborator: (none)
• Enrollment: 560
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 15.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: transdermal nicotine patch; Drug: placebo patch	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 560 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Transdermal Nicotine in Female Patients at High Risk for PONV
• Study Start Date: Apr 1, 2009
• Anticipated Primary Completion Date: Apr 1, 2012
• Anticipated Study Completion Date: Apr 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121

Sponsors and Collaborators

• Ochsner Health System

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Joseph AM, Fu SS. Safety issues in pharmacotherapy for smoking in patients with cardiovascular disease. Prog Cardiovasc Dis. 2003 May-Jun;45(6):429-41. Review.
• Joseph AM, Norman SM, Ferry LH, Prochazka AV, Westman EC, Steele BG, Sherman SE, Cleveland M, Antonuccio DO, Hartman N, McGovern PG. The safety of transdermal nicotine as an aid to smoking cessation in patients with cardiac disease. N Engl J Med. 1996 Dec 12;335(24):1792-8. Erratum in: N Engl J Med. 2007 Jun 14;356(24):2554. Antonnucio, DO [corrected to Antonuccio, DO].
• Tzivoni D, Keren A, Meyler S, Khoury Z, Lerer T, Brunel P. Cardiovascular safety of transdermal nicotine patches in patients with coronary artery disease who try to quit smoking. Cardiovasc Drugs Ther. 1998 Jul;12(3):239-44.

• Responsible Party: Stuart Hart, Director of Obstetric Anesthesiology, Ochsner Health System
• ClinicalTrials.gov Identifier: NCT00775749
• Other Study ID Numbers: PONV
• First Posted: Oct 20, 2008
• Last Update Posted: Oct 26, 2011
• Last Verified: Oct 1, 2011

• Keywords provided by Stuart Hart, Director of Obstetric Anesthesiology, Ochsner Health System: post operative nausea and vomiting; gynecological surgery; outpatient surgery; nicotine patch; laparoscopic surgery
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Nicotine

Study Results

No Results Posted as of Oct 26, 2011