Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
Recruiting now
Conditions studied: Postoperative Delirium, Postoperative Cognitive Dysfunction
In brief
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.
Key facts
- Study ID
- NCT06761573
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 84
- Starts
- 2020-07-07
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-01-07
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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.
Where it is running
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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