EUCTR2014-003720-43-CZ
Active, not recruiting
Phase 1
Prevention of nicotine abstinence in critically ill patients after major surgery - NIKOTI
DrugsNiquitin Clear 21mg
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- icotin abstinence delirium
- Sponsor
- Fakultní nemocnice Ostrava
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 subjects for this age range 20
Exclusion Criteria
- •Age \<18 years.
- •failure to obtain informed consent approved by the Ethics Committee.
- •Patients undergoing neurosurgical operation, patients diagnosed with cranial trauma.
- •Patients diagnosed with psychiatric illness.
- •Known allergy to nicotine or any other component of the transdermal patch NiQuitin CLEAR 21 mg.
- •Known allergy to surgical bandage Curapor.
- •patients with recent heart attack, unstable or worsening angina or patients with serious heart rhythm disorders, patients with a fresh stroke.
- •Pregnant and nursing women.
- •Patients with concomitant treatment with products containing nicotine.
Outcomes
Primary Outcomes
Not specified
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