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/25928189Actively Recruiting
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-07
84
Participants Needed
1
Research Sites
N/A
Total Duration
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
Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
M
Maria Paola Lauretta, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Martin Soehle, Alexander Dittmann, Richard K Ellerkmann...
https://pubmed.ncbi.nlm.nih.gov/25928189