Smoking Cessation Program in the Preadmission Clinic

Study Overview
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Brief Summary
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Main Hypothesis: The multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by quit line) in the preoperative clinic is more effective than the simple preoperative smoking intervention (brief advice and provision of information about the quit lines ) in terms of short-term and long-term quit rates Objectives: To evaluate the effectiveness and feasibility of a multifaceted intervention (preoperative counseling, pharmacotherapy by varenicline and follow up by the quit line) in the preoperative clinic to help surgical patients quit smoking perioperatively and for the long-term.

Official Title
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Smoking Cessation Program in the Preadmission Clinic:The Combination of Counseling, Pharmacotherapy and Quit Line

Conditions
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Smoking

Intervention / Treatment
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* Drug: Smoking cessation counselling group
* Other: Control group:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who smoke more than 10 cigarettes per day for more than 1 year And had no period of smoking abstinence longer than 3 months in the past year. Patients who are scheduled to have any elective surgery next 7 to 60 days. Patients > 18 years of age Exclusion Criteria: Patients unwilling or unable to give informed consent Patients who are pregnant and breast feeding Patients with any psychiatric disorder Patients who used nicotine replacement / bupropion within previous 3 months Cardiovascular disease within the past 6 months Any serious or unstable disease within the past 6 months Drug or alcohol abuse within the past year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation group<br>Counselling, Pharmacotherapy and Smokers Help Line | Drug: Smoking cessation counselling group<br>* The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up<br>|
| Other: Control group<br>Brief informatin about quitting and smokers help line | Other: Control group:<br>* Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-surgery counseling for quit smoking | In order to determine the prevalence of abstinence in long-term follow up (4, 12, 24 and 52 weeks), patients will be asked the following questions: Have you been abstinent from smoking for the past four weeks? (4-week abstinence) Do you currently smoke cigarettes everyday? (point prevalence) Have you been abstinent from smoking since the last time you quit smoking? (continuous abstinence) | 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perioperative complications | Secondary outcome measures that will be studied are as follows: The changes in the number of cigarettes consumed per day or 'stage of change' at 4, 12, 24 and 52 weeks after the initial assigned target quit date. The incidence of perioperative complications (until 30 days after surgery) as well as medication-related adverse events (and serious adverse events) will also be recorded (only those who in the smoking-cessation program). | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, quit, surgery, anesthesia, champix