Nicotine Dependence
Conditions
Keywords
nicotine patch, placebo, critically ill patients, delirium, prevention
Brief summary
The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.
Detailed description
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. Patients in a group with placebo receive a placebo patch within 24 hours after surgery. This patch is replaced every day. Delirium is evaluated in the same way - CAM - ICU test. The maximum length of the placebo intervention is 7 days.
Interventions
DRUGNicotine patch
The patients will receive a nicotine patch for the period of a maximum of 7 days.
OTHERPlacebo patch
The patients will receive a placebo patch for the period of a maximum of 7 days.
Sponsors
University Hospital Ostrava
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The participant, care provider and investigator will be masked as far as the treatment provided is concerned.
Intervention model description
The patients will be randomized into two study groups, with the active substance and placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * An assumption of hospitalization at the intensive care unit (ICU) after surgery * Signed Informed consent
Exclusion criteria
* Age ˂ 18 years * Non-signing of the informed consent * Patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke * Patients with psychiatric diseases * Nicotine, Curapor or Hydrocoll allergy * Patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia * Pregnant and breastfeeding patients * Patients with nicotine treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium episodes | maximum of 7 days | The number of delirium episodes, defined according to the CAM-ICU test, in the course of the seven days with the patch attached will be measured in both groups of study subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of days with delirium | maximum of 7 days | Change in the number of days with delirium, defined according to the CAM-ICU test, by 20%, in the course of the seven days with the patch attached among the study subjects with the nicotine patch. |
| Ventilator-hours | maximum of 7 days | The number of ventilator-hours will be observed in both groups of study subjects. |
Countries
Czechia
Outcome results
None listed