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Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

Recruitingn/aAges 18 Years - 90 YearsAllIRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT06761573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins
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Where

1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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