Assessing brain activity patterns to predict postoperative delirium

Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study

This study is testing if monitoring brain activity during head and neck or plastic surgery can help predict if patients will experience confusion or memory problems afterwards.

Quick facts

• Study type: Observational
• Enrollment: 84 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT06761573 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients over 70 years old or those with specific risk factors undergoing head and neck surgery.

Not a fit: Patients with severe anesthetic risk or significant neurological history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction and management of postoperative delirium and cognitive dysfunction in at-risk surgical patients.

How similar studies have performed: While studies on postoperative delirium exist, this specific approach using bilateral bispectral index monitoring is novel and has not been extensively tested.

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.

Where this trial is running

Bologna

• 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

Conditions Postoperative Delirium; Postoperative Cognitive Dysfunction; Bilateral Bispectral Index; Head&Neck Surgery; Plastic Surgery; Interhemispheric asymmetries