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

Primary Purpose

Postoperative Nausea and Vomiting

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

transdermal nicotine patch

placebo patch

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring post operative nausea and vomiting, gynecological surgery, outpatient surgery, nicotine patch, laparoscopic surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

Sites / Locations

Ochsner Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

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

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.

Outcomes

Primary Outcome Measures

The primary outcome measure is whether the patient experienced post-operative nausea and/or vomiting.

Secondary Outcome Measures

The secondary outcome is to assess how many episodes of post-operative nausea and/or vomiting the patient experiences.

Full Information

NCT ID

NCT00775749

First Posted

October 17, 2008

Last Updated

April 10, 2023

Sponsor

Ochsner Health System

1. Study Identification

Unique Protocol Identification Number

NCT00775749

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Withdrawn

Why Stopped

The study is not feasible with the number of subjects needed to complete it.

Study Start Date

April 2009 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ochsner Health System

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

post operative nausea and vomiting, gynecological surgery, outpatient surgery, nicotine patch, laparoscopic surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

transdermal nicotine patch

Other Intervention Name(s)

Nicoderm CQ Step 3

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo patch

Other Intervention Name(s)

Tegaderm patch

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stuart R Hart, M.D.

Organizational Affiliation

Ochsner Health Systems

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Heather S Porter

Organizational Affiliation

Ochsner Health Systems

Official's Role

Study Director

Facility Information:

Facility Name

Ochsner Clinic Foundation

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12800126

Citation

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. doi: 10.1053/pcad.2003.YPCAD14.

Results Reference

background

PubMed Identifier

8943160

Citation

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. doi: 10.1056/NEJM199612123352402. Erratum In: N Engl J Med. 2007 Jun 14;356(24):2554. Antonnucio, DO [corrected to Antonuccio, DO].

Results Reference

background

PubMed Identifier

9784902

Citation

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. doi: 10.1023/a:1007757530765.

Results Reference

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PubMed Identifier

9821833

Citation

Davidson M, Epstein M, Burt R, Schaefer C, Whitworth G, McDonald A. Efficacy and safety of an over-the-counter transdermal nicotine patch as an aid for smoking cessation. Arch Fam Med. 1998 Nov-Dec;7(6):569-74. doi: 10.1001/archfami.7.6.569.

Results Reference

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PubMed Identifier

12946238

Citation

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Results Reference

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

Khoury Z, Comans P, Keren A, Lerer T, Gavish A, Tzivoni D. Effects of transdermal nicotine patches on ambulatory ECG monitoring findings: a double-blind study in healthy smokers. Cardiovasc Drugs Ther. 1996 May;10(2):179-84. doi: 10.1007/BF00823596.

Results Reference

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PubMed Identifier

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Citation

Mahmarian JJ, Moye LA, Nasser GA, Nagueh SF, Bloom MF, Benowitz NL, Verani MS, Byrd WG, Pratt CM. Nicotine patch therapy in smoking cessation reduces the extent of exercise-induced myocardial ischemia. J Am Coll Cardiol. 1997 Jul;30(1):125-30. doi: 10.1016/s0735-1097(97)00128-9.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Results Reference

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

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