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Completed

NCT Number: NCT01260233

Effect of a Perioperative Smoking Cessation Program on Smoking Cessation/Reduction and Perioperative Complications

The purpose of this study is to determine whether a perioperative smoking cessation program, implemented at least 3 weeks prior to elective surgery, is effective in increasing rates of smoking cessation or reduction. Intraoperative and immediate postoperative complications will also be compared.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

About this study

Previous studies have shown that patients have up to one-third fewer complications after surgery when they quit smoking at least several weeks before surgery. Nicotine replacement therapy (which relieves cravings for cigarettes) and support by healthcare professionals have been shown to help patients quit smoking, particularly when encountering a major health event (e.g. surgery). In addition, quitting smoking in preparation for surgery sometimes results in quitting for a longer period of time after surgery, giving these patients the health benefits of long-term smoking cessation such as reduced rates of cancer and heart disease.

The preadmission clinic at St. Joseph's Health Care, London, Ontario, is assessing how effective a new 'Stop Smoking' program is for patients preparing for surgery. The program will include brief counselling in the clinic, smoking cessation brochures, six weeks of free transdermal nicotine replacement therapy and a referral to the Canadian Cancer Society's Smokers' Helpline telephone advice line. Patients that are smokers and preparing for their elective surgery will be invited to join the study, then be assigned to a group that either participates in the program or not. These groups will then be compared in terms of success at quitting smoking and complication rates around the time of surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • smokers (defined as those that smoke at least 2 cigarettes per day and have smoked within the last 7 days)
  • over age 18
  • presenting to preadmission clinic at St. Joseph's Health Care at least 3 weeks prior to scheduled date of surgery

Exclusion criteria

  • less than age 18
  • poor proficiency in English language
  • pregnant
  • breastfeeding
  • unable to consent due to severe mental illness or dementia
  • actively participating in another smoking cessation trial

Treatment and study plan

Smoking cessation program

Other

Smoking cessation program includes:

  • brief smoking cessation counselling by preadmission nurse (less than 5 minutes)
  • smoking cessation brochures
  • referral to the Smokers' Helpline telephone advice line, run by the Canadian Cancer Society
  • free transdermal nicotine replacement therapy for 6 weeks Smokers of 10 cigarettes per day or more receive 4 weeks of nicoderm 21mg/day, 1 week of 14mg/day and 1 week of 7mg/day Smokers of less than 10 cigarettes per day receive 4 weeks of nicoderm 14mg/day and 2 weeks of 7mg/day

Other names: nicoderm, transdermal nicotine replacement therapy, nicotine replacement patch

Primary outcomes

  1. smoking cessation

    Time frame: date of surgery

    Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.

Secondary outcomes

  1. smoking cessation/reduction

    Time frame: day of surgery

    Smoking cessation/reduction by self-report. Smoking cessation defined as zero cigarettes in the 7 days before surgery (but exhaled CO > 7ppm) Reduction defined as 50% or less of initial self-report.

  2. Intraoperative complications and immediate post-operative complications

    Time frame: day of surgery

    Events occurring in the operating room or post-anesthetic care unit (PACU) as reported by a blinded anesthesiologist or blinded PACU nurse:

    Cardiovascular complications, Respiratory complications, Other (detailed description exceeds character limits)

  3. Time until PACU readiness for discharge / actual time in PACU

    Time frame: day of surgery

    The time of arrival in PACU until the time the patient is deemed ready for discharge in accordance with hospital routine scoring system. The actual time spent in PACU (arrival until discharge) will also be compared.

    Patients bypassing PACU (e.g. patients having only sedation transferred directly from the operating room to surgical daycare prior to discharge home) will be considered separately.

  4. Unanticipated hospital admission

    Time frame: day of surgery

    Patient booked as one-day stay, but later admitted to inpatient ward.

  5. Hospital length of stay

    Time frame: until hospital discharge

    For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.

  6. Smoking cessation at 12 months

    Time frame: 1 year

    Self-reported smoking zero cigarettes in the 7 days prior to phone call. Phone call will occur at any time during the 12th month after surgery.

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • University of Western Ontario, Canada

Registry information

Official study title

The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Dec 15, 2010
Registry last updated
Aug 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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