Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Dec 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how differences in brain activity might help predict whether patients will experience confusion or memory problems after surgery, specifically in those undergoing head and neck or plastic surgery. The researchers want to understand if certain brain patterns, measured during and after surgery, can identify patients who are more likely to develop postoperative delirium (POD) or cognitive dysfunction (POCD) within the first 30 to 90 days after their operation.

To participate in this study, patients should be 65 years or older and have at least three specific risk factors, such as being over 70 years old, male, a smoker, or having high blood pressure. Not everyone can join; for example, patients with serious medical conditions or recent surgeries are excluded. Those who do participate can expect to undergo standard surgical procedures while their brain activity is monitored, helping researchers gather important information about brain function and recovery after surgery. This trial aims to improve our understanding of postoperative complications and potentially enhance care for future patients.

Gender

ALL

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.