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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04875182
Acronym
ZolDel
Enrollment
73
Registered
2021-05-06
Start date
2021-05-01
Completion date
2021-09-02
Last updated
2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Brief summary

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

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).

Interventions

DIAGNOSTIC_TESTEvaluation of Delirium development

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

Sponsors

Dr. Gokhan Vural
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
preoperative Zonulinin the preoperative 24. hourThe relation between postoperative delirium development and preoperative blood zonulin levels. The correlation between them will be analyzed by statistical analysis.
postoperative ZonulinAt the postoperative 72. hourThe relation between postoperative delirium development and postoperative blood zonulin levels The correlation between them will be analyzed by statistical analysis.

Secondary

MeasureTime frameDescription
preoperative Interleukin-8in the preoperative 24. hourThe relation between postoperative delirium development and preoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.
postoperative Interleukin-8At the postoperative 72. hourThe relation between postoperative delirium development and postoperative blood interleukin-8 levels. The correlation between them will be analyzed by statistical analysis.

Other

MeasureTime frameDescription
Postoperative painAt the postoperative 0., 12., 24 hoursThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026