Bilateral Bispectral Index, Asymmetries and Post-operative Delirium (DELBIS)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Postoperative Delirium; Postoperative Cognitive Dysfunction

Treatments: Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins

Study type: Observational

Funder types: Other

Identifiers

NCT06761573

DELBIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

84 participants in 1 patient group

Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD

Description:

Each recruited patient, once on the operating bed, will be monitored with two BIS sensor, applied on the forehead in a non-invasive way, each for hemisphere. BIS Vista® monitor will be connected to our off-line laptop and software VitalDB will record: right\&left BIS, BSR, Total Power, SEF, EMG, SQI and two BIS curves. Values of the study variables will be extract in these specific moments:(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. A daily follow-up for the first 5 post-operative days will verify the onset of POD and a telephone follow-up will be performed at 30 and 90 post-operative days to verify the onset of POD and POCD (CAM scale, 6-CIT scale and EQ50 for tracheostomized patients).

Treatment:

Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins