Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Nicotine patch
- Conditions
- Nicotine Dependence
- Sponsor
- University Hospital Ostrava
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Incidence of delirium episodes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Nicotine
The patients randomized into this study arm will receive a medical intervention - nicotine patch for the period of a maximum of 7 days.
Intervention: Nicotine patch
Placebo
The patients randomized into this study arm will receive a placebo patch for the period of a maximum of 7 days.
Intervention: Placebo patch
Outcomes
Primary Outcomes
Incidence of delirium episodes
Time Frame: 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 Outcomes
- Ventilator-hours(maximum of 7 days)
- Change in the number of days with delirium(maximum of 7 days)