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Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

Recruiting
18-90 years
All
Phase N/A

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Overview

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.

Description

Values of the study variables will be extract in these specific moments (considering a delay of thirty seconds between the in vivo phenomenon and the instrument): (t1) BIS probe application (t2) 60" before GA administration (t3) 60" after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation. Daily follow-up for the first five post-operative days is performed in order to verify the onset of POD and a telephone follow-up at thirty and ninety post-operative days in order to verify the onset of POD / POCD.

CAM scale will be used for the diagnosis of POD; while for the diagnosis of POCD, 6-CIT test will be used, the EQ50 test in the case of tracheostomized patients.

Eligibility

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.

Study details
    Postoperative Delirium
    Postoperative Cognitive Dysfunction

NCT06761573

IRCCS Azienda Ospedaliero-Universitaria di Bologna

15 October 2025

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