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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260233
• Other study ID #: R-10-476
• Secondary ID: 17342
• Status: Completed
• Phase: N/A
• First received: December 13, 2010
• Last updated: August 22, 2013
• Start date: October 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2013
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: August 2013
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking
• Tobacco Use

Intervention

Other:
• Smoking 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

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	smoking cessation	Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.	date of surgery	No
Secondary	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.	day of surgery	No
Secondary	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)	day of surgery	No
Secondary	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.	day of surgery	No
Secondary	Unanticipated hospital admission	Patient booked as one-day stay, but later admitted to inpatient ward.	day of surgery	No
Secondary	Hospital length of stay	For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.	until hospital discharge	No
Secondary	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.	1 year	No