Smoking Cessation Program in the Preadmission Clinic

NCT01320462 | Completed

• 1 other identifier: WS836526
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Smoking

Keywords

Smoking; quit; surgery; anesthesia; champix

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• perioperative complications

  3 months after surgery

Study Arms (2)

Smoking cessation group

EXPERIMENTAL

Counselling, Pharmacotherapy and Smokers Help Line

Drug: Smoking cessation counselling group

Control group

OTHER

Brief informatin about quitting and smokers help line

Other: Control group:

Interventions

Smoking cessation counselling group DRUG

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

Smoking cessation group

Control group: OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Pfizer: collaborator

Study Sites (2)

Toronto Western Hospital, Department of Aneshtesia

Toronto, Ontario, M5T2S8, Canada

Location

Mount Sinai Hospital, Department of Anesthesia

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Smoking

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Frances Chung, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Anesthesiologist

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: December 1, 2010
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 5, 2017

Record last verified: 2016-06

Locations

CA (2)