Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age> 70;
Male sex; or ASA III;
Smoker;
High blood pressure;
Disqualifiers
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);
Stroke;
Dementia;
Cerebral aneurysm;
Trial population
The study plans to enroll all patients undergoing head\&neck surgery and plastic surgery, who meet the inclusion criteria. Patients will be screened and definitively enrolled after checking the inclusion and exclusion criteria. The study population, therefore, is represented by a minority of patients undergoing head\&neck and plastic surgery, who have "a priori" increased risk of developing POD. The setting of the proposed study is the operating theaters of the operating block where the Anesthesia and Pain Therapy service is located, directed by Prof. Rita Maria Melotti, in pavilion 5 in the Policlinico Sant'Orsola-Malpighi in Bologna, Italy.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins
DeviceIn 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.
Treatment groups
84 Participants
are divided into 1 treatment groupGroup A: Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD1 intervention
Trial outcomes
Primary outcomes
1
Correlation between ASYM (EEG-derived cerebral hemispheric asymmetries) at specific intraoperative timepoints and development of Postoperative Delirium (POD) or Postoperative Cognitive Dysfunction (POCD)
Primary aim of the study is to describe values of ASYM, during different intraoperative phases, in patients who develop -or do not- POD within 5 postoperative days and POCD at 30 and 90 postoperative days. Bilateral BIS monitor records values of right and left BIS scores (dimensionless number EEG-derived from 0 to 100), therefore, the asymmetry between the two (ASYM) evaluated as the total power difference for the frequencies between 0 and 30 Hz between right and left hemisphere \[Formula 1\]. An asymmetry of 50% indicates the same power in both hemispheres; while an ASYM lower than 50% indicates a lower power in the left hemisphere than in the right. Formula 1: ASYM= total power left/(total power left+total power right) x 100 Dispersion of ASYM will be expressed as the mean right to left difference ±2 standard deviation.The statistical difference of the model will be evaluated with the use of ANOVA tests.
Time frame
between 30 and 90 postoperative daysSecondary outcomes
1
Incidence of Postoperative Delirium (POD) and Postoperative Cognitive Dysfunction (POCD) in head&neck and plastic surgery
Secondary outcome of the study is to describe the incidence of Postoperative Delirium (POD) and Postoperative Cognitive Dysfunction (POCD) in patients undergoing head\&neck and plastic surgery considered at "priori" high risk for development of POD with CAM scale and CIT-6 scale
Time frame
follow-up at 5, 30 and 90 postoperative days2
Correlation between values of bilateral BSR, bilateral sBIS, bilateral sEMG at specific intraoperative timepoints and development of POD or POCD
Secondary outcome is to evaluate differences in BIS monitor derived values: bilateral bilateral burst suppression ratio (BSR), bilateral bispectral index (BIS), bilateral elecromyography (sEMG), during the different intraoperative phases (repeated measures), between the group of patients who develop at least one episode of POD within 5 days and the group of patients who develop at least one episode of POCD within 90 postoperative days. Mean Differences ±2 standard deviation of these values will be evaluated in relation to the primary outcome (DPO and DCPO) through the use of a linear mixed effects model based on both inter-patient and inter-evaluation variability. The statistical difference of the model will be evaluated with the use of ANOVA tests.
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 extubation3
Secondar outcomes is to evaluate inter and intra-patient variability of EEG-derived values at specific intraoperative timepoints
Describe the inter- and intra-patient variability of the electroencephalographic derived values, during different intraoperative phases of general anesthesia. Differences in ASYM, bilateral BSR, bilateral sBIS, bilateral sEMG values during different peri-operative stages will be described (exploratory outcome)
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 extubationSponsors and contacts
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Source ClinicalTrials.gov