Assessing brain activity patterns to predict postoperative delirium

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the interhemispheric asymmetry of brain activity using the Bilateral Bispectral Index in patients undergoing head and neck or plastic surgery. It will monitor patients at various stages during and after surgery to determine the relationship between brain activity patterns and the development of postoperative delirium (POD) and cognitive dysfunction (POCD). Patients will be followed for 30 days post-surgery for POD and 90 days for POCD, using specific diagnostic scales to assess outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Maria Paola Lauretta, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Maria Paola Lauretta, MD
• Email: mariapaola.lauretta@aosp.bo.it
• Phone: 0512143444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.