Postoperative DeliriumDELBISNCT06761573
Bilateral Bispectral Index, Asymmetries and Post-operative Delirium
An observational study of Postoperative Delirium and Postoperative Cognitive Dysfunction, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Delirium, Postoperative Cognitive Dysfunction
- What is being tested?
- Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jul 2020to Dec 2026
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- -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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Maria Paola Lauretta, MD, EDAIC, 0512143444, mariapaola.lauretta@aodp.bo.it
Maria Paola Lauretta, MD
About this study
Official title: Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study
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.
Read the 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.
- Being tested
- Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins
- Keywords
- Bilateral Bispectral Index, Head&Neck Surgery, Plastic Surgery, Postoperative Delirium, Postoperative Cognitive Dysfunction, Interhemispheric asymmetries
- Medical subject headings
- Emergence Delirium, Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery beginsDevice
Also called CAM and CIT scales for diagnosis of POD and POCD will be post operativelly administrated to our patients
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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
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.
Measured: 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
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start7 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Paola Lauretta, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761573
- Sponsor's protocol ID
- DELBIS
- Acronym
- DELBIS
- Status last verified
- Dec 2024
- First submitted
- 23 Mar 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25928189
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT06761573
- Acronym / sponsor ID
- DELBIS / DELBIS
- Keywords
- Bilateral Bispectral Index, Head&Neck Surgery, Plastic Surgery, Postoperative Delirium, Postoperative Cognitive Dysfunction, Interhemispheric asymmetries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD | – | Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery beginsEach 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- -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;
Key exclusion criteria (15 listed)
- 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:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery beginsAlso: CAM and CIT scales for diagnosis of POD and POCD will be post operativelly administrated to our patientsIn 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. | Device | Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 25928189Soehle 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.
- PubMedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Paola Lauretta, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Postoperative Cognitive Dysfunction, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Paola Lauretta, MD (0512143444, mariapaola.lauretta@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.