Phase 4
Completed N=30
The END Perioperative Smoking Pilot Study
Smoking · Nicotine Addiction · Surgery
Source: ClinicalTrials.gov NCT02482233 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO) — 2; 3 Participants
◆ Published Evidence
Established
62citations · ~8 / year
E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial.
Summary
The purpose of this pilot randomized trial is to determine the feasibility of e-cigarettes and telephone counselling (compared to transdermal nicotine replacement and telephone counselling) as a harm-reduction tool that may lead to increased smoking cessation in the perioperative setting in smokers presenting for elective surgery at the San Francisco Veterans Affairs Medical Center. Secondary outcomes include acceptability of e-cigarettes over transdermal nicotine replacement, length-of-stay in the post-anesthesia care unit, hospital length-of-stay, postoperative complications within the first 30-days, and smoking status 8-weeks after randomization. This pilot study is designed to provide the preliminary data necessary to plan and fund a larger-scale randomized clinical trial that will assess the utility of e-cigarettes in achieving smoking cessation perioperatively. Our ultimate goal is to add to the limited existing data on the safety and efficacy of e-cigarette use in smoking cessation, specifically in the perioperative setting where the risks of continued smoking are great and the motivation to stop is high.
Linked Publications
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E-cigarettes versus nicotine patches for perioperative smoking cessation: a pilot randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO) |
2; 3 | — |
| SECONDARY Frequency of Use of Product - Number Reporting Use Daily or Most Days |
6; 16 | — |
| SECONDARY Report of How Helpful the Product Was for Quitting |
5; 6 | — |
| SECONDARY How Satisfied the Patient Was With the Product (E-cigarette or Patch) |
5; 5.5 | — |
| SECONDARY How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others |
7; 6 | — |
| SECONDARY Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO) |
0; 3 | — |
| SECONDARY Smoking Reduction |
7; 13 | — |
| SECONDARY Number of Participants With Dual Use |
3; 2 | — |
| SECONDARY Spirometry - FEV1/FVC Change |
-32.2; -1.6; -38.1; 2.0 | — |
| SECONDARY Spirometry - FEV1 |
-236; -163; -300; 292 | — |
| SECONDARY Cotinine Level (Change in) |
106; 19; 34; -48 | — |
| SECONDARY Number of Participants With Postoperative Complications (Composite) |
6; 5; 2; 5 | — |
| SECONDARY Long-term Smoking Status - Use of Conventional Cigarettes |
1; 5 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
3; 10; 1; 1 | — |
| SECONDARY Number of Participants Postoperative Complications (Composite) |
2; 5 | — |
Eligibility Criteria
Inclusion Criteria
- adults (age >18)
- any gender
- scheduled to undergo elective surgery at the San Francisco Veterans Affairs Medical Center (SFVAMC)
- daily smoker, based on self-report of at least 2 cigarettes/day and having smoked in the last 7 days
- presenting to the anesthesia preoperative (APO) clinic at least 3 days preoperatively
Exclusion Criteria
- emergency surgery (booked <24 hours preoperatively)
- consumers of non-cigarette forms of tobacco only (pipe, smokeless tobacco) or marijuana only
- already enrolled in a smoking cessation trial
- current smoking cessation pharmacotherapy
- daily user of e-cigarettes
- previous adverse reaction to e-cigarette or transdermal nicotine
- poor proficiency of English language¸as indicated by need for an interpreter (including family members) at the preadmission visit
- lacking capacity for consent (e.g. due to mental illness or dementia), as indicated by consent for surgery and other medical procedures being obtained from a substitute decision maker
- pregnant or breastfeeding
- unstable cardiac condition (unstable angina, unstable arrhythmia)
Data sourced from ClinicalTrials.gov (NCT02482233) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.