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Completed

NCT Number: NCT03847155

Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

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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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Confusion Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotine patch

Drug

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

Placebo patch

Other

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

Primary outcomes

  1. 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

  1. Change in the number of days with delirium

    Time frame: maximum of 7 days

    Change in the number of days with delirium, defined according to the CAM-ICU test, by 20%, in the course of the seven days with the patch attached among the study subjects with the nicotine patch.

  2. Ventilator-hours

    Time frame: maximum of 7 days

    The number of ventilator-hours will be observed in both groups of study subjects.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2019
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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