Actively Recruiting

Age: 18Years - 90Years
All Genders
ID06761573

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-07

84

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to describe the value of interhemispheric asymmetry (ASYM) measured by bilateral Bispectral Index (BIS) monitoring during different intraoperative and perioperative phases. It focuses on patients undergoing head and neck or plastic surgery who are at a higher risk of developing postoperative delirium (POD) within 30 days and postoperative cognitive dysfunction (POCD) within 90 days after surgery. Each participant will have two BIS sensors placed on their forehead to monitor brain activity in each hemisphere non-invasively during surgery. Data will be collected at specific timepoints including before anesthesia, after muscle relaxation, intubation, surgical incision, end of anesthesia, and after extubation. Daily assessments for POD will occur for five days post-surgery, with follow-up phone calls at 30 and 90 days to monitor POD and POCD using CAM, 6-CIT, and EQ50 tests. During the study, researchers will monitor brain asymmetries and other EEG-derived parameters to investigate their correlation with POD and POCD. Participants will undergo regular clinical evaluations, cognitive testing, and monitoring in the hospital and via telephone. The primary outcome is the correlation between intraoperative asymmetry values and postoperative delirium or cognitive dysfunction occurrence. The study duration includes perioperative monitoring and follow-up extending up to 90 days after surgery.

CONDITIONS

Brief Title

Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing head and neck surgery with at least three risk factors for delirium
  • Risk factors include: age over 70, male sex, ASA III health status, smoker, or high blood pressure
  • Age between 18 and 90 years
Not Eligible

You will not qualify if you...

  • Anesthetic risk ASA greater than III or undergoing urgent or emergency surgery
  • History of stroke, dementia, cerebral aneurysm, brain tumor, head trauma, epilepsy, diabetes, previous brain surgery, or chronic psychiatric illness requiring treatment
  • Surgery within the previous two weeks
  • Hospital stay expected to be less than five days
  • Inability to understand Italian or English
  • Age under 18 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Surgery day

Participants undergoing head and neck or plastic surgery have bilateral Bispectral Index (BIS) monitors applied to their forehead before surgery begins to measure brain activity at specific intraoperative timepoints.

1 visit (in-person) on surgery day

Post-operative Follow-up

Duration - 5 days

Participants are followed daily for the first 5 days after surgery to monitor for the onset of postoperative delirium (POD).

Daily visits for 5 days post-surgery

Long-term Monitoring

Duration - 90 days

Participants receive telephone follow-up at 30 and 90 days after surgery to assess for postoperative delirium (POD) and postoperative cognitive dysfunction (POCD).

2 telephone follow-up calls at 30 and 90 days after surgery

Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138

Actively Recruiting

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Research Team

M

Maria Paola Lauretta, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study.

Martin Soehle, Alexander Dittmann, Richard K Ellerkmann...

https://pubmed.ncbi.nlm.nih.gov/25928189