Postoperative Delirium in the ICU Setting of an Eastern European Centre

Study Overview
=================
Brief Summary
-----------------
The study targets postoperative delirium in patients undergoing major abdominal surgery, with the aim to evaluate the functional baseline and proteomics implicated in pathogenesis, prevention strategies (such as anesthesia depth monitoring) and incidence in certain population groups.

Official Title
-----------------
Postoperative Delirium: a Complex Prediction Model in Patients Undergoing Major Abdominal Surgery

Conditions
-----------------
Postoperative Delirium, Cognitive Impairment

Intervention / Treatment
-----------------
* Device: BIS monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA risk I-III; patients undergoing complex digestive surgery, such as esophagectomy, total gastrectomy, hemicolectomy, cephalic duodenopancreatectomy, hepatic resection. Exclusion Criteria: the impossibility of obtaining the patient's consent/his decisional incapacity; patients who underwent neurosurgery for cerebrospinal lesions / cardiac surgery under cardiopulmonary bypass; prediagnosed senile/vascular/mixed dementia.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIS monitoring<br>Patients in this group will be subjected to Bispectral index-guided general anesthesia. | Device: BIS monitoring<br>* The depth of anesthesia will be monitored using Bispectral Index values.<br>|
| PRST score monitoring<br>Patients in this group will be subjected PRST score-guided general anesthesia. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction model for postoperative delirium (POD) in major abdominal surgery | Developing an accesible algorithm to anticipate the occurence of postoperative delirium, based on functional baseline and proteomics, in adult patients subjected to major abdominal surgical interventions. | 3-4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia depth monitoring and the incidence of postoperative delirium | Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium | 0-4 days postoperatively | 
| Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting |  | during ICU hospitalization | 
| Postoperative delirium incidence in surgical patients - subgroup - communism survivors |  | during ICU hospitalization | 
| Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitors |  | during ICU hospitalization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative delirium, abdominal surgery, malondialdehyde, S100B protein, Tau protein, pNF-H, Bispectral Index, anesthesia depth, general anesthesia