ClinicalTrials.gg
CompletedNCT01260233Updated Aug 26, 2013

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

An interventional study of Smoking cessation program in Smoking and Tobacco Use, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Smoking
  • Tobacco Use

Keywords

  • smoking cessation
  • complications
  • cigarettes
  • preoperative
  • perioperative
  • surgery
  • education
  • nicotine replacement therapy
03

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 168 is above the median of 117 across 250 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
168 participants (actual)

Study arms

  • No intervention
    Control

    No intervention. Patients will receive standard of care.

  • Experimental
    Smoking cessation program

    Receives smoking cessation program

    Other: Smoking cessation program

Interventions

  • OtherSmoking cessation program

    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

    Also known as: nicoderm, transdermal nicotine replacement therapy, nicotine replacement patch

06

What researchers measure

Primary outcomes

  1. smoking cessation

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

    Time frame: date of surgery

Secondary outcomes

  1. smoking cessation/reduction

    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.

    Time frame: day of surgery

  2. Intraoperative complications and immediate post-operative complications

    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)

    Time frame: day of surgery

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

    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.

    Time frame: day of surgery

  4. Unanticipated hospital admission

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

    Time frame: day of surgery

  5. Hospital length of stay

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

    Time frame: until hospital discharge

  6. Smoking cessation at 12 months

    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.

    Time frame: 1 year

07

Study locations

1 site
  • St. Joseph's Health Care
    London, Ontario N6A 4V2, Canada
08

References and documents

Publications

  • Lee SM, Landry J, Jones PM, Buhrmann O, Morley-Forster P. Long-term quit rates after a perioperative smoking cessation randomized controlled trial. Anesth Analg. 2015 Mar;120(3):582-587. doi: 10.1213/ANE.0000000000000555. PubMed 25695576 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01260233
Collaborators
University of Western Ontario, Canada
Responsible party
Philip Jones (Associate Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Dec 15, 2010
Start date
Oct 2010
Primary completion
May 2012
Completion
Aug 2013
Last update
Aug 26, 2013

Study contacts

Philip Jones, MD, FRCPC
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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