Smoking
Conditions
Keywords
cigarettes, surgery, Smokers scheduled for elective surgery
Brief 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.
Detailed 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.
Interventions
DRUGNicotine Lozenge
Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day and a 2 minute behavioral intervention. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
DRUGPlacebo Lozenge
Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day and a 2 minute behavioral intervention.
BEHAVIORALAbstinence Advisement
A brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Current cigarette smoker, defined as \>100 cigarettes lifetime consumption and self report of smoking every day * Scheduled for elective non-cardiac surgery
Exclusion criteria
* An inability to understand consent procedures * History of an allergic reaction to nicotine replacement therapy * History of sustained ventricular tachycardia * Untreated hyperthyroidism or pheochromocytoma * Currently utilizing pharmacologic agents specifically to treat nicotine dependence, including nicotine replacement therapy and bupropion (for a stop-smoking indication) * Active (within the past 12 months) non-nicotine drug dependence * Females who are pregnant or lactating * Patients with phenylketonuria, because the lozenges contain aspartame, which is metabolized to phenylalanine. * Lack of access to a telephone, as one follow-up will be performed using this means.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exhaled Carbon Monoxide Concentration | Morning of surgery, pre-operatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Abstinence | Morning of surgery, pre-operatively | Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Time to Last Cigarette | Morning of surgery, pre-operatively | — |
| Minnesota Nicotine Withdrawal Score | Morning of surgery, pre-operatively | This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms. |
| Self-reported Abstinence From Smoking | Post-operative day 8 | — |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from patients evaluated at the Mayo Clinic Pre-Operative Evaluation Center located in Rochester, Minnesota, in preparation for elective surgery.
Participants by arm
| Arm | Count |
|---|---|
| Nicotine Lozenges Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. | 22 |
| Placebo Lozenge Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.
Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times. | 24 |
| Total | 46 |
Baseline characteristics
| Characteristic | Nicotine Lozenges | Placebo Lozenge | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 14 | 49.8 years STANDARD_DEVIATION 12.8 | 52.7 years STANDARD_DEVIATION 13.2 |
| Fagerstrom Test for Nicotine Dependence | 6.7 Units on a scale STANDARD_DEVIATION 1.2 | 6.1 Units on a scale STANDARD_DEVIATION 1.4 | 6.4 Units on a scale STANDARD_DEVIATION 1.3 |
| In-patient surgery In-Patient Elective Surgery | 12 participants | 13 participants | 25 participants |
| In-patient surgery Out-Patient Elective Surgery | 10 participants | 11 participants | 21 participants |
| Minnesota Nicotine Withdrawal Score | 1.5 units on a scale STANDARD_DEVIATION 0.9 | 1.5 units on a scale STANDARD_DEVIATION 1 | 1.5 units on a scale STANDARD_DEVIATION 1 |
| Number of cigarettes per day | 16.8 Cigarettes per day STANDARD_DEVIATION 6.7 | 17.9 Cigarettes per day STANDARD_DEVIATION 7.2 | 17.2 Cigarettes per day STANDARD_DEVIATION 7 |
| Pre-operative Abstinence Intention Did not intend to abstain prior to surgery | 4 participants | 5 participants | 9 participants |
| Pre-operative Abstinence Intention Intended to abstain prior to surgery | 18 participants | 19 participants | 37 participants |
| Region of Enrollment United States | 22 participants | 24 participants | 46 participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 24 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 24 |
| serious Total, serious adverse events | 0 / 22 | 0 / 24 |
Outcome results
Primary
Exhaled Carbon Monoxide Concentration
Time frame: Morning of surgery, pre-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Lozenges | Exhaled Carbon Monoxide Concentration | 8.3 Parts per million | Standard Deviation 7.5 |
| Placebo Lozenge | Exhaled Carbon Monoxide Concentration | 12.7 Parts per million | Standard Deviation 10.9 |
Comparison: A two-sided p value of less than or equal to 0.05 was considered statistically significant.p-value: 0.12t-test, 2 sided
Secondary
Self-reported Abstinence
Mean number who reported abstinence from smoking from the the time of baseline assessment until the morning of surgery.
Time frame: Morning of surgery, pre-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenges | Self-reported Abstinence | 16 participants |
| Placebo Lozenge | Self-reported Abstinence | 13 participants |
p-value: 0.23Fisher Exact
Other Pre-specified
Minnesota Nicotine Withdrawal Score
This item was measured using the Minnesota Nicotine Withdrawal Questionnaire, self-reported for the prior 24 hour period. This questionnaire consists of 15 items, each rated from 0 to 4, with a possible score of 0 to 60. A lower score indicates lesser withdrawal symptoms, and a higher score indicates greater withdrawal symptoms.
Time frame: Morning of surgery, pre-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Lozenges | Minnesota Nicotine Withdrawal Score | 1.3 units on a scale | Standard Deviation 1 |
| Placebo Lozenge | Minnesota Nicotine Withdrawal Score | 1.4 units on a scale | Standard Deviation 0.9 |
p-value: 0.93t-test, 2 sided
Other Pre-specified
Self-reported Abstinence From Smoking
Time frame: Post-operative day 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nicotine Lozenges | Self-reported Abstinence From Smoking | 11 participants |
| Placebo Lozenge | Self-reported Abstinence From Smoking | 11 participants |
p-value: 1Fisher Exact
Other Pre-specified
Self-reported Time to Last Cigarette
Time frame: Morning of surgery, pre-operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotine Lozenges | Self-reported Time to Last Cigarette | 21.8 Hours | Standard Deviation 19.5 |
| Placebo Lozenge | Self-reported Time to Last Cigarette | 16.7 Hours | Standard Deviation 11.3 |
p-value: 0.29t-test, 2 sided