NCT06761573 Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
| NCT ID | NCT06761573 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Postoperative Delirium |
| Study Type | OBSERVATIONAL |
| Enrollment | 84 participants |
| Start Date | 2020-07-07 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief Summary
The primary objective of the study is to describe the value of interhemispheric asymmetry (ASYM), during the different intra- and peri-operative phases, in those patients who develop or do not develop post-operative delirium (POD) during the first 30 post-operative days and postoperative cognitive disfunction (POCD) in the first 90 post-operative days, in a population undergoing head\&neck and plastic surgery with a priori increased probability of POD.
Eligibility Criteria
Inclusion Criteria: -Patients, undergoing head\&neck surgery, who have at least 3 of the following criteria (to establish "a priori" increased risk of POD): * Age\> 70; * Male sex; or ASA III; * Smoker; * High blood pressure; Exclusion Criteria: * ASA IV, V or ASA IE, IIE, IIIE (patients with anesthetic risk ASA\>III and those undergoing urgent-emergency surgery will be excluded from the study); * Past positive medical history for: * Stroke; * Dementia; * Cerebral aneurysm; * Intracranial mass; * Head trauma; * Epilepsy; * Diabetes mellitus; * Previous neurosurgical intervention; * Psychiatric illnesses requiring chronic treatment; * Patients undergoing surgery in the previous two weeks; * Patients whose hospitalization duration is estimated to be less than five days; * Lack of understanding of the Italian language or English; * Age \<18 years.