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Postoperative Delirium in the ICU Setting of an Eastern European Centre

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05474872
Enrollment
100
Registered
2022-07-26
Start date
2022-07-15
Completion date
2026-01-31
Last updated
2024-01-09

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

Conditions

Cognitive Impairment, Postoperative Delirium

Keywords

postoperative delirium, abdominal surgery, malondialdehyde, S100B protein, Tau protein, pNF-H, Bispectral Index, anesthesia depth, general anesthesia

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.

Interventions

The depth of anesthesia will be monitored using Bispectral Index values.

Sponsors

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prediction model for postoperative delirium (POD) in major abdominal surgery3-4 yearsDeveloping 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

MeasureTime frameDescription
Anesthesia depth monitoring and the incidence of postoperative delirium0-4 days postoperativelyAssessing 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) settingduring ICU hospitalization
Postoperative delirium incidence in surgical patients - subgroup - communism survivorsduring ICU hospitalization
Postoperative delirium incidence in surgical patients - subgroup - patients with no relatives/visitorsduring ICU hospitalization

Other

MeasureTime frameDescription
The influence of POD on length of stay (LOS), unplanned ICU re-admission, cognitive decline and mortalityduring patient hospitalizationEvaluating the possibility of a correlation between the occurence of POD and prolonged hospitalization, a prerequisite for ICU re-admittance or further cognitive deterioration / mortality.

Countries

Romania

Contacts

Primary ContactMara Mihaescu, PhD student
mara.mihaescu05@gmail.com+ 40 747540266
Backup ContactDaniela Ionescu, MD,PhD
dionescuati@yahoo.com

Outcome results

None listed

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