Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-23

Study Completion Date

2021-02-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nicotine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be randomized into two study groups, with the active substance and placebo.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The participant, care provider and investigator will be masked as far as the treatment provided is concerned.

Study Groups

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Nicotine

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

Group Type EXPERIMENTAL

Nicotine patch

Intervention Type DRUG

The patients will receive a nicotine patch for the period of a maximum of 7 days.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo patch

Intervention Type OTHER

The patients will receive a placebo patch for the period of a maximum of 7 days.

Interventions

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Nicotine patch

The patients will receive a nicotine patch for the period of a maximum of 7 days.

Intervention Type DRUG

Placebo patch

The patients will receive a placebo patch for the period of a maximum of 7 days.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No