AnesthesiaTIARANCT04765046

The Influence of Age on EEG Signals and Consciousness During Anesthesia

A study testing Bispectral (BIS™) Complete Monitoring System in people with Anesthesia, run by Medtronic - MITG at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anesthesia
What is being tested?: Bispectral (BIS™) Complete Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 2 sitesin 2 countries
Study dates: 18 Aug 2021to 3 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A potential subject may be included for participation in the study if the subject has/is:
≥18 years of age
American Society of Anesthesiologists (ASA) physical status I-III
Able and willing to participate in the study and sign the informed consent form
Will undergo non-ambulatory elective surgery under general anesthesia
Has an expected surgery time >2 hours

Who cannot join

A potential subject will be excluded from participating in the study if the subject has/is:
Pregnant
Unwilling to undergo EEG measurement
Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.
Known or suspected electroencephalograph abnormality (e.g., epilepsy or scarring)

Show all 9Show fewer

Presence of a major psychiatric condition such as Bipolar disorder/ schizophrenia/ Alzheimer's disease/ dementia/ Parkinson's disease /major depression
Severe visual or auditory disorder
Cannot understand or is unwilling to perform the study assessments, according to the investigator's judgment

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Israel1 site

Rambam Health Care Campus
Haifa

Other trials in Israel

Netherlands1 site

Leiden University Medical Center
Leiden

Other trials in Netherlands

About this study

Official title: The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

Read the detailed description

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population. The BIS system will be used on-label as approved in the respective study site countries to monitor and non-invasively measure and interpret brain wave activity directly related to the effects of anesthetic agents. The study's purpose is to evaluate the relationship between BIS parameters, age, and depth of anesthesia in patients undergoing surgery under general anesthesia.

Conditions: Anesthesia
Being tested: Bispectral (BIS™) Complete Monitoring System
Keywords: Bispectral index

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bispectral (BIS™) Complete Monitoring SystemDevice
The BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.

Study groups in NCT04765046
Study group	Role	What they receive
BIS™ System	Other	Enrolled subjects who are undergoing a standard of care elective surgery under general anesthesia, will be equipped with the BIS system to non-invasively measure and interpret brain waive activity directly related to the effects of anesthetic agents during the surgery duration. Receives: Device: Bispectral (BIS™) Complete Monitoring System

What is being measured

The primary outcome is the main question the study is designed to answer.

BIS50
The Bispectral Index (BIS) value, a scale 0-100 with 0 being no brain activity and 100 being fully conscious, at which 50% of subjects are anesthetized at a level they are considered uncounscious based on the MOAA/S score of 0-2
Measured: 8 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 20213 Apr 2023

First posted21 Feb 2021
Study start18 Aug 2021
Primary completion3 Apr 2023
Study completion3 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for AnesthesiaStudies of the same condition, open and under way.
More trials run by Medtronic - MITGThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04765046
Sponsor's protocol ID: MDT18067TIARA
Acronym: TIARA
Status last verified: Jun 2024
First submitted: 8 Jan 2021
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia. 2007 Oct;11(4):175-7.
PubMed 19582189
Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
PubMed 24937564
Glass PS, Bloom M, Kearse L, Rosow C, Sebel P, Manberg P. Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers. Anesthesiology. 1997 Apr;86(4):836-47. doi: 10.1097/00000542-199704000-00014.
PubMed 9105228
Flaishon R, Windsor A, Sigl J, Sebel PS. Recovery of consciousness after thiopental or propofol. Bispectral index and isolated forearm technique. Anesthesiology. 1997 Mar;86(3):613-9. doi: 10.1097/00000542-199703000-00013.
PubMed 9066327
Schwab HS, Seeberger MD, Eger EI 2nd, Kindler CH, Filipovic M. Sevoflurane decreases bispectral index values more than does halothane at equal MAC multiples. Anesth Analg. 2004 Dec;99(6):1723-1727. doi: 10.1213/01.ANE.0000136467.47996.70.
PubMed 15562061
Hans P, Dewandre PY, Brichant JF, Bonhomme V. Comparative effects of ketamine on Bispectral Index and spectral entropy of the electroencephalogram under sevoflurane anaesthesia. Br J Anaesth. 2005 Mar;94(3):336-40. doi: 10.1093/bja/aei047. Epub 2004 Dec 10.
PubMed 15591328
Sengupta S, Ghosh S, Rudra A, Kumar P, Maitra G, Das T. Effect of ketamine on bispectral index during propofol--fentanyl anesthesia: a randomized controlled study. Middle East J Anaesthesiol. 2011 Oct;21(3):391-5.
PubMed 22428494
Alkire MT. Quantitative EEG correlations with brain glucose metabolic rate during anesthesia in volunteers. Anesthesiology. 1998 Aug;89(2):323-33. doi: 10.1097/00000542-199808000-00007.
PubMed 9710389
Werner P, Heinik J, Mendel A, Reicher B, Bleich A. Examining the reliability and validity of the Hebrew version of the Mini Mental State Examination. Aging (Milano). 1999 Oct;11(5):329-34. doi: 10.1007/BF03339808.
PubMed 10631883
Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, Morley JE, Chumlea W, Salva A, Rubenstein LZ, Garry P. Overview of the MNA--Its history and challenges. J Nutr Health Aging. 2006 Nov-Dec;10(6):456-63; discussion 463-5.
PubMed 17183418
Perna S, Francis MD, Bologna C, Moncaglieri F, Riva A, Morazzoni P, Allegrini P, Isu A, Vigo B, Guerriero F, Rondanelli M. Performance of Edmonton Frail Scale on frailty assessment: its association with multi-dimensional geriatric conditions assessed with specific screening tools. BMC Geriatr. 2017 Jan 4;17(1):2. doi: 10.1186/s12877-016-0382-3.
PubMed 28049443
Anderson O, Davis R, Hanna GB, Vincent CA. Surgical adverse events: a systematic review. Am J Surg. 2013 Aug;206(2):253-62. doi: 10.1016/j.amjsurg.2012.11.009. Epub 2013 May 1.
PubMed 23642651

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Influence of Age on EEG Signals and Consciousness During Anesthesia (TIARA)
ClinicalTrials.gov ID: NCT04765046
Acronym / sponsor ID: TIARA / MDT18067TIARA
Conditions: Anesthesia
Keywords: Bispectral index
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Medtronic - MITGIndustry (pharma, biotech, devices)
Study start: 18 Aug 2021 (actual)
Primary completion: 3 Apr 2023 (actual)
Study completion: 3 Apr 2023 (actual)
First posted: 21 Feb 2021 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a prospective, multi-center, non-invasive, interventional, data collection study to improve the current BIS algorithm in the elderly adult population.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BIS™ System	Other	Device: Bispectral (BIS™) Complete Monitoring SystemEnrolled subjects who are undergoing a standard of care elective surgery under general anesthesia, will be equipped with the BIS system to non-invasively measure and interpret brain waive activity directly related to the effects of anesthetic agents during the surgery duration.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

≥18 years of age
American Society of Anesthesiologists (ASA) physical status I-III
Able and willing to participate in the study and sign the informed consent form
Will undergo non-ambulatory elective surgery under general anesthesia
Has an expected surgery time >2 hours

Key exclusion criteria (9 listed)

A potential subject will be excluded from participating in the study if the subject has/is:
Pregnant
Unwilling to undergo EEG measurement
Undergone brain surgery procedure or had a cerebrovascular accident or severe head trauma in the last 10 years
Alcohol or illicit drug use, which prevents normal functioning in society or has led to organ toxicity. Chronic use of opioids, narcotics, or analgesics, which may limit a subject's responsiveness to analgesic dosages.

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
Bispectral (BIS™) Complete Monitoring SystemThe BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.	Device	BIS™ System

Primary outcome

BIS50
Time frame: 8 hours
The Bispectral Index (BIS) value, a scale 0-100 with 0 being no brain activity and 100 being fully conscious, at which 50% of subjects are anesthetized at a level they are considered uncounscious based on the MOAA/S score of 0-2

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BIS™ System	90	72

Primary outcome: BIS50

Time frame: 8 hours. Mean (95% Confidence Interval). Unit: index

Measure	Age 18-64 n = 29	Age 65+ n = 28
Value	70.9 (67.8 to 73.7)	74.7 (72.0 to 77.1)

Adverse events

Time frame: Adverse events were collected from enrollment to study exit (directly after completion of data collection during surgery, approximately 8 hours). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Age 18-64	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Age 65+	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19582189Kanonidou Z, Karystianou G. Anesthesia for the elderly. Hippokratia. 2007 Oct;11(4):175-7.
Background: PubMed 24937564Punjasawadwong Y, Phongchiewboon A, Bunchungmongkol N. Bispectral index for improving anaesthetic delivery and postoperative recovery. Cochrane Database Syst Rev. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3.
Background: PubMed 9105228Glass PS, Bloom M, Kearse L, Rosow C, Sebel P, Manberg P. Bispectral analysis measures sedation and memory effects of propofol, midazolam, isoflurane, and alfentanil in healthy volunteers. Anesthesiology. 1997 Apr;86(4):836-47. doi: 10.1097/00000542-199704000-00014.
Background: PubMed 9066327Flaishon R, Windsor A, Sigl J, Sebel PS. Recovery of consciousness after thiopental or propofol. Bispectral index and isolated forearm technique. Anesthesiology. 1997 Mar;86(3):613-9. doi: 10.1097/00000542-199703000-00013.
Background: PubMed 15562061Schwab HS, Seeberger MD, Eger EI 2nd, Kindler CH, Filipovic M. Sevoflurane decreases bispectral index values more than does halothane at equal MAC multiples. Anesth Analg. 2004 Dec;99(6):1723-1727. doi: 10.1213/01.ANE.0000136467.47996.70.
Background: PubMed 15591328Hans P, Dewandre PY, Brichant JF, Bonhomme V. Comparative effects of ketamine on Bispectral Index and spectral entropy of the electroencephalogram under sevoflurane anaesthesia. Br J Anaesth. 2005 Mar;94(3):336-40. doi: 10.1093/bja/aei047. Epub 2004 Dec 10.
Background: PubMed 22428494Sengupta S, Ghosh S, Rudra A, Kumar P, Maitra G, Das T. Effect of ketamine on bispectral index during propofol--fentanyl anesthesia: a randomized controlled study. Middle East J Anaesthesiol. 2011 Oct;21(3):391-5.
Background: PubMed 9710389Alkire MT. Quantitative EEG correlations with brain glucose metabolic rate during anesthesia in volunteers. Anesthesiology. 1998 Aug;89(2):323-33. doi: 10.1097/00000542-199808000-00007.
Background: PubMed 10631883Werner P, Heinik J, Mendel A, Reicher B, Bleich A. Examining the reliability and validity of the Hebrew version of the Mini Mental State Examination. Aging (Milano). 1999 Oct;11(5):329-34. doi: 10.1007/BF03339808.
Background: PubMed 17183418Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, Morley JE, Chumlea W, Salva A, Rubenstein LZ, Garry P. Overview of the MNA--Its history and challenges. J Nutr Health Aging. 2006 Nov-Dec;10(6):456-63; discussion 463-5.
Background: PubMed 28049443Perna S, Francis MD, Bologna C, Moncaglieri F, Riva A, Morazzoni P, Allegrini P, Isu A, Vigo B, Guerriero F, Rondanelli M. Performance of Edmonton Frail Scale on frailty assessment: its association with multi-dimensional geriatric conditions assessed with specific screening tools. BMC Geriatr. 2017 Jan 4;17(1):2. doi: 10.1186/s12877-016-0382-3.
Background: PubMed 23642651Anderson O, Davis R, Hanna GB, Vincent CA. Surgical adverse events: a systematic review. Am J Surg. 2013 Aug;206(2):253-62. doi: 10.1016/j.amjsurg.2012.11.009. Epub 2013 May 1.
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. This study is not recruiting at the moment.

Albert Dahan, MD PhD principal investigator

Leiden University Medical Center

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bispectral (BIS™) Complete Monitoring System in people with Anesthesia, run by Medtronic - MITG at 2 sites in 2 countries.

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 6 inclusion and 9 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: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel, Netherlands. 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?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BIS50 (time frame: 8 hours). 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 NCT04765046, which also lists 12 linked publications.

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 3 Jul 2024.