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

NCT ID: NCT04875182

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-09-02

Brief Summary

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

Detailed Description

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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).

Conditions

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Postoperative Delirium

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Evaluation of Delirium development

Intervention Type DIAGNOSTIC_TEST

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

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.

Evaluation of Delirium development

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Evaluation of Delirium development

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Postoperative pain evaluation

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Gokhan Vural

OTHER

Sponsor Role lead

Responsible Party

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Dr. Gokhan Vural

Anesthesiologist Dr. Gokhan

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gökhan vural

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Locations

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Muğla Sıtkı Koçman University

Muğla, Menteşe, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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26.02.2020- 04/VI

Identifier Type: -

Identifier Source: org_study_id

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