Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins.
- Who it may be relevant to
- Registry conditions: Postoperative Delirium, Postoperative Cognitive Dysfunction. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- Correlation between ASYM (EEG-derived cerebral hemispheric asymmetries) at specific intraoperative timepoints and development of Postoperative Delirium (POD) or Postoperative Cognitive Dysfunction (POCD) [Time frame: between 30 and 90 postoperative days]
Secondary outcome measures (3)
- Incidence of Postoperative Delirium (POD) and Postoperative Cognitive Dysfunction (POCD) in head&neck and plastic surgery [Time frame: follow-up at 5, 30 and 90 postoperative days]
- Correlation between values of bilateral BSR, bilateral sBIS, bilateral sEMG at specific intraoperative timepoints and development of POD or POCD [Time frame: Intraoperative phase: (t1) BIS probe application (t2) 60 seconds before GA administration (t3) 60 seconds after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation]
- Secondar outcomes is to evaluate inter and intra-patient variability of EEG-derived values at specific intraoperative timepoints [Time frame: Intraoperative phase: (t1) BIS probe application (t2) 60 seconds before GA administration (t3) 60 seconds after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation]
Eligibility criteria
Inclusion criteria
-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;
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Publications
- Soehle M, Dittmann A, Ellerkmann RK, Baumgarten G, Putensen C, Guenther U. Intraoperative burst suppression is associated with postoperative delirium following cardiac surgery: a prospective, observational study. BMC Anesthesiol. 2015 Apr 28;15:61. doi: 10.1186/s12871-015-0051-7. PMID 25928189
Identifiers
NCT: NCT06761573 · DELBIS