Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)
NCT ID: NCT00775749
Last Updated: 2023-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2009-04-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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1
The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Ochsner Health System
OTHER
Responsible Party
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Stuart Hart
Director of Obstetric Anesthesiology
Principal Investigators
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Stuart R Hart, M.D.
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health Systems
Heather S Porter
Role: STUDY_DIRECTOR
Ochsner Health Systems
Locations
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Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Countries
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References
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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.
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.
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.
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.
Head KA, Jurenka JS. Inflammatory bowel disease Part 1: ulcerative colitis--pathophysiology and conventional and alternative treatment options. Altern Med Rev. 2003 Aug;8(3):247-83.
Flood P, Daniel D. Intranasal nicotine for postoperative pain treatment. Anesthesiology. 2004 Dec;101(6):1417-21. doi: 10.1097/00000542-200412000-00023.
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.
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.
Richardson CE, Morgan JM, Jasani B, Green JT, Rhodes J, Williams GT, Lindstrom J, Wonnacott S, Peel S, Thomas GA. Effect of smoking and transdermal nicotine on colonic nicotinic acetylcholine receptors in ulcerative colitis. QJM. 2003 Jan;96(1):57-65. doi: 10.1093/qjmed/hcg007.
Shytle RD, Silver AA, Wilkinson BJ, Sanberg PR. A pilot controlled trial of transdermal nicotine in the treatment of attention deficit hyperactivity disorder. World J Biol Psychiatry. 2002 Jul;3(3):150-5. doi: 10.3109/15622970209150616.
Silver AA, Shytle RD, Philipp MK, Wilkinson BJ, McConville B, Sanberg PR. Transdermal nicotine and haloperidol in Tourette's disorder: a double-blind placebo-controlled study. J Clin Psychiatry. 2001 Sep;62(9):707-14. doi: 10.4088/jcp.v62n0908.
Yang YK, Nelson L, Kamaraju L, Wilson W, McEvoy JP. Nicotine decreases bradykinesia-rigidity in haloperidol-treated patients with schizophrenia. Neuropsychopharmacology. 2002 Oct;27(4):684-6. doi: 10.1016/S0893-133X(02)00325-1.
Other Identifiers
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PONV
Identifier Type: -
Identifier Source: org_study_id
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