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

NCT00775749 | Withdrawn DMC

• 1 other identifier: PONV
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Study Arms (2)

1

EXPERIMENTAL

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

Drug: transdermal nicotine patch

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.

Drug: placebo patch

Interventions

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.

Also known as: Nicoderm CQ Step 3

1

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.

Also known as: Tegaderm patch

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Related Publications (12)

• 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.

  PMID: 12800126 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.

  PMID: 8943160 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.

  PMID: 9784902 BACKGROUND

• 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.

  PMID: 9821833 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.

  PMID: 12946238 RESULT

• Flood P, Daniel D. Intranasal nicotine for postoperative pain treatment. Anesthesiology. 2004 Dec;101(6):1417-21. doi: 10.1097/00000542-200412000-00023.

  PMID: 15564950 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.

  PMID: 8842510 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.

  PMID: 9207632 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.

  PMID: 12509650 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.

  PMID: 12478880 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.

  PMID: 11681767 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.

  PMID: 12377405 RESULT

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Vomiting

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Stuart R Hart, M.D.

  Ochsner Health Systems

  PRINCIPAL INVESTIGATOR

• Heather S Porter

  Ochsner Health Systems

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Obstetric Anesthesiology

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: April 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

US (1)