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
Age: 18Years - 90Years
All Genders
ID06761573
Bilateral Bispectral Index and Brain Activity Differences in High Risk Patients Undergoing Head and Neck or Plastic Surgery Observational Study on Postoperative Delirium and Cognitive Dysfunction
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-07
84
Participants Needed
1
Research Sites
334 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the value of brain activity differences between the two sides of the brain, called interhemispheric asymmetry (ASYM), during various phases of surgery and anesthesia. This study focuses on patients undergoing head and neck or plastic surgery who have a higher risk of developing postoperative delirium (POD) within 30 days after surgery and postoperative cognitive dysfunction (POCD) within 90 days. The goal is to see how ASYM relates to the occurrence of these cognitive problems after surgery. Before surgery, a device called the Bilateral Bispectral Index (BIS) monitor is placed on the forehead to record brain activity. Measurements are taken at specific times, including before anesthesia, after muscle relaxation, during intubation, at surgical incision, at the end of anesthesia, and 10 minutes after extubation. The study observes patients undergoing general anesthesia and surgery, using the BIS device to monitor brain hemisphere differences throughout these stages. Participants are followed daily for the first five days after surgery to check for signs of delirium using the CAM scale. Telephone follow-ups occur at 30 and 90 days post-surgery to assess for delirium and cognitive dysfunction using the 6-CIT test or EQ50 test for certain patients. The study measures correlations between brain activity asymmetry during surgery and later cognitive outcomes, with careful monitoring over the three-month period after surgery.
CONDITIONS
Official Title
Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing head & neck surgery who have at least 3 of the following: age over 70; male sex; ASA III classification; smoker; high blood pressure
- Age 18 to 90 years
You will not qualify if you...
- Patients with anesthetic risk ASA higher than III or undergoing urgent/emergency surgery
- History of stroke
- History of dementia
- History of cerebral aneurysm
- History of intracranial mass
- History of head trauma
- History of epilepsy
- History of diabetes mellitus
- Previous neurosurgical intervention
- Psychiatric illnesses requiring chronic treatment
- Surgery in the previous two weeks
- Hospitalization expected to be less than five days
- Inability to understand Italian or English
- Age under 18 years
AI-Screening
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1
2
3
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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