Smoking Cessation Program in the Preadmission Clinic

N/ACompletedNCT01320462

University Health Network, Toronto296 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

296

Conditions

Smoking

Interventions

Smoking cessation counselling groupDRUG

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

Control group:OTHER

Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, Canada

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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)

Time frame: 1 year after surgery

Secondary Outcomes

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).

Time frame: 3 months after surgery

Data from ClinicalTrials.gov

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