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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Delirium
• Intervention / Treatment: Diagnostic test: Evaluation of Delirium development

Detailed Description

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).

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Menteşe
    • Muğla, Menteşe, Turkey (Türkiye), 48000
      • Muğla Sıtkı Kocman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Postoperative pain scores of the patients will recorded by using a numerical rating scale.; Other Names: Postoperative pain evaluation
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; Postoperative pain scores of the patients will recorded by using a numerical rating scale.; Other Names: Postoperative pain evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative Interleukin-8	The relation between postoperative delirium development and preoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.	in the preoperative 24. hour
postoperative Interleukin-8	The relation between postoperative delirium development and postoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.	At the postoperative 72. hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	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.	At the postoperative 0., 12., 24 hours

Collaborators and Investigators

• Sponsor: Dr. Gokhan Vural
• Investigators: Principal Investigator: Gökhan vural, Muğla Sıtkı Kocman University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 2, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium
• Other Study ID Numbers: 26.02.2020- 04/VI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no IPD will be shared with other researchers or anyone else

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No