Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

NCT06761573 | Recruiting DMC

• 1 other identifier: DELBIS
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction

Keywords

Bilateral Bispectral Index; Head&Neck Surgery; Plastic Surgery; Postoperative Delirium; Postoperative Cognitive Dysfunction; Interhemispheric asymmetries

Outcome Measures

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.

  between 30 and 90 postoperative days

Secondary Outcomes (3)

• Incidence of Postoperative Delirium (POD) and Postoperative Cognitive Dysfunction (POCD) in head&neck and plastic surgery

  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

  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

  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

Study Arms (1)

Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD

Each recruited patient, once on the operating bed, will be monitored with two BIS sensor, applied on the forehead in a non-invasive way, each for hemisphere. BIS Vista® monitor will be connected to our off-line laptop and software VitalDB will record: right\&left BIS, BSR, Total Power, SEF, EMG, SQI and two BIS curves. Values of the study variables will be extract in these specific moments:(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. A daily follow-up for the first 5 post-operative days will verify the onset of POD and a telephone follow-up will be performed at 30 and 90 post-operative days to verify the onset of POD and POCD (CAM scale, 6-CIT scale and EQ50 for tracheostomized patients).

Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins

Interventions

Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins DEVICE

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.

Also known as: CAM and CIT scales for diagnosis of POD and POCD will be post operativelly administrated to our patients

Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Related Publications (1)

• 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 BACKGROUND

Related Links

• PubMed

MeSH Terms

Conditions

Emergence Delirium; Postoperative Cognitive Complications

Interventions

Complementary Therapies

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maria Paola Lauretta, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Paola Lauretta, MD

CONTACT

0512143444; mariapaola.lauretta@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: January 7, 2025
• Study Start: July 7, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)