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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00586482 |
Nicotine replacement therapy (NRT) helps patients maintain prolonged abstinence; whether it might also be efficacious in helping smokers maintain preoperative "fasting" from smoking is not known. The goal of this study is to determine how to best decrease smokers' exposure to cigarette smoke immediately before surgery. The specific aim of this study is to test the hypothesis that NRT in the form of nicotine lozenges will decrease the exposure to cigarette smoke prior to surgery. This is a randomized, double blinded, placebo controlled clinical trial examining the efficacy of the nicotine lozenge in increasing preoperative abstinence from cigarettes in patients scheduled for elective surgery. Current smokers scheduled for elective surgery will be recruited in the Mayo Clinic Rochester Preoperative Evaluation Center and will receive a brief practice-based intervention encouraging preoperative abstinence for at least 12 hours before admission to the surgical facility. They will be randomized to receive either active or placebo lozenge. The primary outcome measure will be exhaled carbon monoxide (CO) concentration measured in the preoperative holding area. The secondary outcome measures will be the self-reported duration of preoperative abstinence from cigarettes, and the self-reported point prevalence abstinence rate measured one week postoperatively.
Condition | Intervention | Phase |
---|---|---|
Smoking |
Drug: nicotine lozenge Drug: Placebo lozenge |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke |
Estimated Enrollment: | 200 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ad lib nicotine lozenges
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Drug: nicotine lozenge
ad lib beginning the night before surgery
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2: Placebo Comparator
Placebo lozenge
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Drug: Placebo lozenge
Ad lib beginning the night before surgery
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David O Warner, MD | 507-255-4288 | warner.david@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | David O Warner, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( David O. Warner, M.D./Professor of Anesthesiology ) |
Study ID Numbers: | 06-002759 |
Study First Received: | December 21, 2007 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00586482 |
Health Authority: | United States: Food and Drug Administration |
cigarettes, surgery Smokers scheduled for elective surgery |
Nicotine polacrilex Smoking Nicotine |
Neurotransmitter Agents Cholinergic Agonists Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Physiological Effects of Drugs Central Nervous System Stimulants Cholinergic Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Ganglionic Stimulants Peripheral Nervous System Agents Central Nervous System Agents |