RecruitingNCT06761573

Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

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

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

84 participants

Start Date

Jul 7, 2020

Study Type

OBSERVATIONAL

Conditions

Postoperative Delirium Postoperative Cognitive Dysfunction

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria5

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 Criteria15

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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Interventions

DEVICEBilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins

In patients undergoing surgery and general anesthesia, the investigators want to examine -using bilateral BIS monitor- synthetic electroencephalographic differences between the two cerebral hemispheres (ASYM) to evaluate any correlation with the development of POD and POCD in the post-operative period.