Effect of Pre-op NRT on Peri-operative Complications and Long-term Abstinence: A Pilot Trial in Patients Undergoing CABG Surgery
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|ClinicalTrials.gov Identifier: NCT02918500|
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Nicoderm Patch||Phase 4|
The aim of this project is to
- To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery.
- To determine the effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery.
- To assess, retroactively, the impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay.
We therefore hypothesize that if NRT is given to smokers during the pre-admission period (1-3 weeks prior to surgery), they are more likely to be biochemically abstinent from cigarette smoking 6 months after hospitalization and will experience fewer peri-operative complications
To assess these measures, we have designed a single site, double-blinded randomized controlled trial at the University of Ottawa Heart Institute (UOHI). Patients who are identified as a smoker at their initial visit to the PAU will undergo a baseline assessment and be randomly assigned (1:1) to either active or placebo 21mg NRT patch. They will wear the patch from that baseline visit until the day of their surgery at UOHI. Following their surgery, they will receive a follow up phone call at 1 and 6 months post-discharge. They will complete a series of short questionnaires to assess their smoking status, stress levels and nicotine withdrawal symptoms. Those who identify themselves as being smoke-free will be asked to complete a carbon monoxide breathing test to chemically validate their smoking status. The study protocol will be reviewed by the Research Ethics board at UOHI and all participants will provide written informed consent prior to undertaking any study activities.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Pre-operative Nicotine Replacement Therapy on Peri-operative Complications and Long-term Abstinence: A Pilot Placebo-controlled Trial in Patients Undergoing Coronary Artery Bypass Surgery (CABG)|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
No Intervention: Placebo
Participants will receive 3 weeks of inactive NRT patches.
Active Comparator: Active
Participants will receive 3 weeks of active NRT patches
Drug: Nicoderm Patch
Nicotine replacement therapy patch
- Carbon monoxide (CO) confirmed abstinence at the time of surgery [ Time Frame: At the time of CABG surgery (will vary with all participants based on their surgical date) and at each follow up visit (1 month and 6 month post-op) ]To determine if pre-operative, (short-term) NRT, 1 to 3 weeks before surgery, improves the long-term quit rates among smokers undergoing elective CABG surgery
- The effect of pre-operative NRT on perceived stress and symptoms of nicotine withdrawal at the time of surgery [ Time Frame: At the time of surgery and each follow up visit (1 & 6 months post-op) ]Measured by the perceived stress scale (PSS-14)
- The impact of pre-operative cessation on peri-operative complications such as infection rates, respiratory failure, myocardial infarction, stroke, sepsis, shock and prolonged hospital stay. [ Time Frame: assessed at the 1 and 6 month post-op follow up visits ]Participants will be asked about any post-operative complications and a retrospective chart review will be completed for all participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918500
|Contact: Evyanne Wooding||613-696-7000 ext firstname.lastname@example.org|
|Contact: Aaron Brautigam||613-696-7000 ext 14377|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4W7|
|Contact: Evyanne Wooding 613-696-7000 ext 17596 email@example.com|
|Contact: Aaron Brautigam 613-696-7000 ext 14377 firstname.lastname@example.org|
|Principal Investigator:||Andrew Pipe, MD||Ottawa Heart Institute Research Corporation|