Postoperative Delirium in the ICU Setting of an Eastern European Centre

Recruiting

• Conditions: Postoperative Delirium; Cognitive Impairment
• Interventions: Device: BIS monitoring

• Registration Number: NCT05474872
• Lead Sponsor: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2022-07-23
• Study First Submitted QC: 2022-07-23
• Study First Posted: 2022-07-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09
• Primary Completion: 2025-07-30
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIS monitoring	BIS monitoring	Patients in this group will be subjected to Bispectral index-guided general anesthesia.

Primary Outcome Measures

Name	Time	Method
Prediction model for postoperative delirium (POD) in major abdominal surgery	3-4 years	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.; This includes investigating a correlation between a set of risk factors, a panel of biomarkers and the occurrence of postoperative delirium in the enrolled patients, respectively.

Secondary Outcome Measures

Name	Time	Method
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
Anesthesia depth monitoring and the incidence of postoperative delirium	0-4 days postoperatively	Assessing the influence of BIS monitoring during general anesthesia on the prevalence of postoperative delirium
Postoperative delirium incidence in surgical patients in the Intensive Care Unit (ICU) setting	during ICU hospitalization

Trial Locations

Locations (1)

Regional Institute of Gastroenterology and Hepatology "Prof.Dr.O.Fodor"; 🇷🇴 Cluj-Napoca, Cluj, Romania