NCT06761573

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 84 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Postoperative Delirium
• Postoperative Cognitive Dysfunction

Interventions

Type	Name	Description
DEVICE	Bilateral 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.

Timeline

• Start date: 2020-07-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-01-07
• Last updated: 2025-01-07

Locations

1 site across 1 country: Italy