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

Postoperative Delirium Clinical Trial

— ZolDel  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875182
• Other study ID #: 26.02.2020- 04/VI
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2021
• Source: Mugla Sitki Koçman University
• Contact: Gökhan vural
• Phone: +905067025348
• Email: gokhan6201[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 Delirium Rating Scale (DRS) for delirium development at the postoperative 1., 2. and 3. days. Patients with a DRS score over 14 points 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: August 30, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

Diagnostic Test:
• Evaluation of Delirium development
Postoperative pain scores of the patients will recorded by using a numerical rating scale.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Gokhan Vural

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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