Trial record 2 of 2424 for:    smoking

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

This study has been completed.
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Philip Jones, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01260233
First received: December 13, 2010
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Smoking
Tobacco Use
Other: Smoking cessation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Perioperative Smoking Cessation Program on Rates of Smoking Cessation/Reduction and Perioperative Complications: a Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • smoking cessation [ Time Frame: date of surgery ] [ Designated as safety issue: No ]
    Smoking cessation is defined as exhaled carbon monoxide (CO) of equal to or less than 7ppm on the day of surgery.


Secondary Outcome Measures:
  • smoking cessation/reduction [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    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.

  • Intraoperative complications and immediate post-operative complications [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

    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)


  • Time until PACU readiness for discharge / actual time in PACU [ Time Frame: day of surgery ] [ Designated as safety issue: No ]

    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.


  • Unanticipated hospital admission [ Time Frame: day of surgery ] [ Designated as safety issue: No ]
    Patient booked as one-day stay, but later admitted to inpatient ward.

  • Hospital length of stay [ Time Frame: until hospital discharge ] [ Designated as safety issue: No ]
    For inpatients only, the time from admission to surgical daycare until the patient is discharged home from the hospital.

  • Smoking cessation at 12 months [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Enrollment: 168
Study Start Date: October 2010
Study Completion Date: August 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
No intervention. Patients will receive standard of care.
Experimental: Smoking cessation program
Receives smoking cessation program
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
Other Names:
  • nicoderm
  • transdermal nicotine replacement therapy
  • nicotine replacement patch

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260233

Locations
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Philip Jones, MD, FRCPC University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Philip Jones, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01260233     History of Changes
Other Study ID Numbers: R-10-476, 17342
Study First Received: December 13, 2010
Last Updated: August 22, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
smoking cessation
complications
cigarettes
preoperative
perioperative
surgery
education
nicotine replacement therapy

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Food Habits
Habits
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014