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

NCT04875182 | Completed

• 1 other identifier: 26.02.2020- 04/VI
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Delirium

Outcome Measures

Primary Outcomes (2)

• preoperative Zonulin

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

  in the preoperative 24. hour

• postoperative Zonulin

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

  At the postoperative 72. hour

Secondary Outcomes (2)

• preoperative Interleukin-8

  in the preoperative 24. hour

• postoperative Interleukin-8

  At the postoperative 72. hour

Other Outcomes (1)

• Postoperative pain

  At the postoperative 0., 12., 24 hours

Study Arms (2)

group delirium

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 Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-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.

Diagnostic Test: Evaluation of Delirium development

group control

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 Delirium Rating Scale for delirium development at the postoperative 1., 2. and 3. days. Patients with a Delirium Rating Scale-Revised-98 score under 11 points for postoperative 72 hours will be included in the Group Control. And second blood samples for zonulin and interleukin-8 levels will be taken at the postoperative 72. hour. Postoperative pain scores of the patients will recorded by using a numerical rating scale.

Diagnostic Test: Evaluation of Delirium development

Interventions

Evaluation of Delirium development DIAGNOSTIC_TEST

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

Also known as: Postoperative pain evaluation

group control; group delirium

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both male and female patients over 65 years of age who will undergo femur neck and inthertrocanteric fracture surgery with regional anesthesia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Gokhan Vural: lead

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

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

Study Officials

• Gökhan vural

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist Dr. Gokhan

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: May 1, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)