Pilot Study: Preoperative Nicotine Lozenges

Smoking Clinical Trial

Official title: The Role of Nicotine Lozenges in Reducing Preoperative Exposure to Cigarette Smoke

Status Completed

Clinical Trial Summary

The goal of this pilot study is to determine the feasibility and potential effect size of nicotine lozenges as an adjunct to maintain brief preoperative abstinence, defined as not smoking the day of surgery.

Clinical Trial Description

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. A 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 any of a wide variety of elective surgical procedures 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. ;

Study Design

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

Related Conditions & MeSH terms

• Smoking

• NCT number: NCT00586482
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: Phase 4
• Start date: August 2006
• Completion date: January 2013