Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

University Hospital Ostrava

Status: Completed

Conditions: Nicotine Dependence

Treatments: Other: Placebo patch; Drug: Nicotine patch

Study type: Interventional

Funder types: Other

Identifiers

NCT03847155

KARIM-09-NICOTINE

2014-003720-43 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 2 patient groups, including a placebo group

Nicotine

Experimental group

Description:

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

Treatment:

Drug: Nicotine patch

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo patch