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

NCT01260233 | Completed

• 2 other identifiers: R-10-47617342
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Tobacco Use

Keywords

smoking cessation; complications; cigarettes; preoperative; perioperative; surgery; education; nicotine replacement therapy

Outcome Measures

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.

  date of surgery

Secondary Outcomes (6)

• smoking cessation/reduction

  day of surgery

• Intraoperative complications and immediate post-operative complications

  day of surgery

• Time until PACU readiness for discharge / actual time in PACU

  day of surgery

• Unanticipated hospital admission

  day of surgery

• Hospital length of stay

  until hospital discharge

Study Arms (2)

Control

NO INTERVENTION

No intervention. Patients will receive standard of care.

Smoking cessation program

EXPERIMENTAL

Receives smoking cessation program

Other: Smoking cessation program

Interventions

Smoking cessation program OTHER

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

Smoking cessation program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 25695576 DERIVED

MeSH Terms

Conditions

Smoking; Tobacco Use; Smoking Cessation

Interventions

Nicotine; Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Therapeutics

Study Officials

• Philip Jones, MD, FRCPC

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: August 1, 2013
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

CA (1)