Bilateral Bispectral Index, Asymmetries and Post-operative Delirium

NCT ID: NCT06761573

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-07
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Postoperative Delirium; Postoperative Cognitive Dysfunction

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Paola Lauretta, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Maria Paola Lauretta, MD

Role: CONTACT

mariapaola.lauretta@aosp.bo.it

0512143444

Facility Contacts

Maria Paola Lauretta, MD, EDAIC

Role: primary

mariapaola.lauretta@aodp.bo.it

0512143444

References

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.

Reference Type: BACKGROUND

PMID: 25928189 (View on PubMed)

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4419445/

PubMed

Other Identifiers

DELBIS

Identifier Type: -

Identifier Source: org_study_id