Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Nicotine (experimental) and Placebo (placebo comparator).

The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.

The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.

The registry classes the interventions as drug and other.

More on the Plan

Patients in a group with medical intervention receive nicotine patch within 24 hours after surgery.

The nicotine patch is replaced every day.

Delirium is evaluated every day by the Confusion Assessment Method (CAM) - ICU test.

The maximum length of intervention is 7 days.

Who Took Part

52 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: Patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery). Age 18 years and above. Patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day). Ex-smokers (if they stopped smoking less than 30 days prior to surgery). Signed Informed consent.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: age ˂ 18 years; non-signing of the informed consent; patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

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

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

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

It started in 2015-09-23 with completion listed for 2021-01-31.

It ran at 1 site in Czechia.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of delirium episodes (time frame: maximum of 7 days).

It also tracked 2 secondary outcomes, for example Change in the number of days with delirium and Ventilator-hours.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 52 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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