The END Perioperative Smoking Pilot Study
Condition: Smoking; Nicotine Addiction; Surgery
MeSH terms: Tobacco Use Disorder
Intervention: ENDD (NJOY); NRT (NicoDerm CQ); telephone counseling; brief advice; brochure
Intervention description: As described above.; As described above.; Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.; Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): "The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."; A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.
Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: electronic cigarette; nicotine replacement therapy; smoking cessation; perioperative

Summary:

      The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes
      and telephone counselling (compared to transdermal nicotine replacement and telephone
      counselling) as a harm-reduction tool that may lead to increased smoking cessation in the
      perioperative setting in smokers presenting for elective surgery at the San Francisco
      Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes
      over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit,
      hospital length-of-stay, postoperative complications within the first 30-days, and smoking
      status 8-weeks after randomization. This pilot study is designed to provide the preliminary
      data necessary to plan and fund a larger-scale randomized clinical trial that will assess the
      utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is
      to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking
      cessation, specifically in the perioperative setting where the risks of continued smoking are
      great and the motivation to stop is high.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adults (age >18)

          -  any gender

          -  scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical
             Center (SFVAMC)

          -  daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in
             the last 7 days

          -  presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively

        Exclusion Criteria:

          -  emergency surgery (booked <24 hours preoperatively)

          -  consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or
             marijuana only

          -  already enrolled in a smoking cessation trial

          -  current smoking cessation pharmacotherapy

          -  daily user of e-cigarettes

          -  previous adverse reaction to e-cigarette or transdermal nicotine

          -  poor proficiency of English language¸as indicated by need for an interpreter
             (including family members) at the preadmission visit

          -  lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by
             consent for surgery and other medical procedures being obtained from a substitute
             decision maker

          -  pregnant or breastfeeding

          -  unstable cardiac condition (unstable angina, unstable arrhythmia)