The END Perioperative Smoking Pilot Study

What Was Tested

The trial (phase 4) is built around Therapeutic nicotine (patch, non-peptide).

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.

It had two arms (groups): ENDD (experimental) and NRT (NicoDerm CQ) (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

It is well-known that smokers suffer more complications and higher risk of mortality after surgery than non-smokers.

Despite this knowledge, it is unclear what clinicians can do to minimize this risk.

Surgery represents a 'teachable moment' that might encourage smokers to engage in permanent cessation.

Smoking cessation initiated in the perioperative period can also promote long-term smoking cessation.

Who Took Part

30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults (age \>18). 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.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: care provider, investigator and outcomes assessor.

It started in 2015-08 with completion listed for 2016-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Smoking Status on the Day of Surgery (48-hour Point-prevalence Abstinence), by Self-report and Confirmed With Exhaled Carbon Monoxide (CO) (time frame: day of surgery (expected average around 1-2 weeks after enrollment/randomization)).

It also tracked 14 secondary outcomes, for example Frequency of Use of Product - Number Reporting Use Daily or Most Days, Report of How Helpful the Product Was for Quitting, How Satisfied the Patient Was With the Product (E-cigarette or Patch), How Likely the Patient Would be to Recommend the Product (E-cigarette or Patch) to Others, Smoking Status 8-weeks After Randomization (Confirmed by Exhaled CO) and Number of Participants With Dual Use.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.