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The study is not feasible with the number of subjects needed to complete it.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The nicotine patch will be applied prior to surgery and remain on the right upper back for 24 hours. |
|
| 2 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transdermal nicotine patch | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart R Hart, M.D. | Ochsner Health Systems | Principal Investigator |
| Heather S Porter | Ochsner Health Systems | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12800126 | Background | 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. | |
| 8943160 | Background | 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. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| placebo patch | Drug | 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. |
|
|
| 9784902 | Background | 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. |
| 9821833 | Result | 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. |
| 12946238 | Result | 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. |
| 15564950 | Result | Flood P, Daniel D. Intranasal nicotine for postoperative pain treatment. Anesthesiology. 2004 Dec;101(6):1417-21. doi: 10.1097/00000542-200412000-00023. |
| 8842510 | Result | 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. |
| 9207632 | Result | 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. |
| 12509650 | Result | 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. |
| 12478880 | Result | 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. |
| 11681767 | Result | 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. |
| 12377405 | Result | 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. |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |