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NCT Number: NCT04875182

The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development

The relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muğla Sıtkı Koçman University

Muğla, Menteşe, 48000, Turkey (Türkiye)

About this study

Patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. Blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. All patients will be evaluated by the Turkish version of the Delirium Rating Scale-Revised-98 (DRS-R-98) for delirium development at the postoperative 1., 2. and 3. days. Patients with a DRS-R-98 score of 11 points or higher will be included in the Group Delirium. And second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis.

Postoperative pain scores of the patients will recorded by using a numerical rating scale (NRS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients over 65 years with mini mental state score > 21, undergoing femur fixation surgery

Exclusion criteria

  • anticholinergic drug use, known epilepsy, Parkinson, Alzheimer's disease, dementia, cognitive function disorder

Treatment and study plan

Evaluation of Delirium development

Diagnostic Test

Postoperative pain scores of the patients will recorded by using a numerical rating scale.

Other names: Postoperative pain evaluation

Primary outcomes

  1. preoperative Zonulin

    Time frame: in the preoperative 24. hour

    The relation between postoperative delirium development and preoperative blood zonulin levels. The correlation between them will be analyzed by statistical analysis.

  2. postoperative Zonulin

    Time frame: At the postoperative 72. hour

    The relation between postoperative delirium development and postoperative blood zonulin levels The correlation between them will be analyzed by statistical analysis.

Secondary outcomes

  1. preoperative Interleukin-8

    Time frame: in the preoperative 24. hour

    The relation between postoperative delirium development and preoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.

  2. postoperative Interleukin-8

    Time frame: At the postoperative 72. hour

    The relation between postoperative delirium development and postoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.

Other outcomes

  1. Postoperative pain

    Time frame: At the postoperative 0., 12., 24 hours

    The relation between postoperative delirium development and postoperative pain score will be documanted. the scores are; zero; have no pain. 0-4 points: mid pain. 5-7points: mild pain. 8-10 points pain score will be named severe pain scores. and The correlation between them will be analyzed by statistical analysis.

Sponsors and collaborators

Lead sponsor

Dr. Gokhan Vural

Other

Registry information

Official study title

The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development in Patients Who Had Femur Fracture Surgery Under Regional Anesthesia

Acronym: ZolDel

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 6, 2021
Registry last updated
Sep 24, 2025

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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