"Prevention of nicotine abstinence in critically ill patients after major surgery"

INTERVENTION: Trade Name: Niquitin Clear 21mg Pharmaceutical Form: Cutaneous patch Pharmaceutical form of the placebo: Cutaneous patch Route of administration of the placebo: Cutaneous use CONDITION: Nicotin abstinence delirium Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: 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. Primary end point(s): The primary efficacy endpoint (primary endpoint) to achieve a statistically significant (significance level p = 0.05) reduction in the incidence of delirium in the group of patients with the application of the study drug. Secondary Objective: The secondary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with the assumption of nicotine abstinence is associated with shorter duration of mechanical ventilation in these patients. Timepoint(s) of evaluation of this end point: When 100 patients complete study after 18 month. SECONDARY OUTCOME: Secondary end point(s): The secondary efficacy parameter (secondary endopoint) to achieve a statistically significant (significance level p = 0.05) reduction of the number of hours of mechanical ventilation in patients. Timepoint(s) of evaluation of this end point: 18 month of Follow‐uo INCLUSION CRITERIA: • Patients older than 18 years. • Patients with the assumption of nicotine abstinence. Prerequisite sudden nicotine abstinence as a risk factor for development of delirium will be assessed by the Test for Nicotine Dependence according to the Fagerstrom. The questionnaire will be filled by the patient within medical examination before anesthesia. • Patients included in the group of patients undergoing major surgery within the abdominal region, urology and thoracic surgery and to subsequent ICU clinics KARIM FNO> 48 hours. Presumption of hospitalization in the ICU clinics KARIM FNO> 48 hours will be determined based on the prediction of the medical assessment. • Obtaining informed consent (signed and dated) approved MEK. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subj