Delirium Clinical Trial
Official title:
The Association Between Minor Brain Injuries and Level of Anesthesia Detected by a New EEG Based Tool, to Delirium and Post-operative Cognitive Dysfunction After Cardiac and Non-cardiac Surgery - a Proof of Concept Study
Verified date | September 2020 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
As the population ages and medical progress is made, many elderly patients that previously
would not have been candidates for surgery are now undergoing operations. In this group of
older patients, brain dysfunction after anesthesia and surgery is well recognized and
categorized into two distinct clinical entities; Post-operative cognitive delirium (POD) and
post-operative cognitive dysfunction (POCD).
Delirium is an acute and fluctuating deterioration in attention accompanied by either a
change in cognition or arousal and is often diagnosed by criteria established in the
Confusion Assessment Method (CAM). Delirium can present as hypoactive (decreased alertness,
motor activity and anhedonia), as hyperactive (agitated and combative) or as mixed forms. Age
and the type of operation are the major risk factors.
Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in
cognition, such as memory and executive function. The most commonly seen problems are memory
impairment and impaired performance on intellectual tasks. In severe cases, it can lead to
inability to perform daily living functions. It was previously found that the presence of
cognitive dysfunction 3 months after non-cardiac surgery was associated with an increased
mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are
not yet fully clear. The risk factors are related to patient characteristics, type of
operation and anesthetic management.
Despite its limitations over-anesthesia as monitored by BIS was at-least correlative with
POD. Therefore it is hopeful that an even more precise evaluation of the level of anesthesia
will improve POD prediction (and thereby prevention) even further.
On the other hand the measure of depth of anesthesia by itself does not provide sufficient
prediction for POCD. In POCD a major role has been assigned to hippocampal damage.
The investigators have recently demonstrated that temporary hippocampal interruptions are
manifested by interhemispheric desynchronization, which are recognized by our new algorithm,
which monitors electrophysiological markers of attention and of perception.
The investigators have developed a unique algorithm for analyzing EEG based on the concept of
monitoring perception and attention and their interhemispheric synchronization.
The aims of this proof of concept study are: (i) to find-out whether interhemispheric
desynchronization of attentional processes is associated with POCD; (ii) to find out whether
the level of anesthesia, is linked primary to POD and secondary to POCD.
Status | Completed |
Enrollment | 160 |
Est. completion date | September 6, 2020 |
Est. primary completion date | September 6, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients 65 years or older undergoing elective cardiac surgery (CABG or valve replacement) or hip/knee replacement. Exclusion Criteria:any of the following criteria; 1. inability or refusal to provide informed consent, 2. significant visual impairment so that the pictures of the confusion assessment method could not be interpreted to accurately test to assess delirium, 3. profound dementia or aphasia that interfered with the assessment of delirium, 4. inability to speak Hebrew/ Russian or Arabic so that a language barrier was not confused with postoperative confusion. 5. Any previously documented major neurologic or psychiatric dysfunction |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Health Care Campus | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Neuroindex Ltd. |
Israel,
Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594. Review. Erratum in: Eur J Anaesthesiol. 2018 Sep;35(9):718-719. — View Citation
Avidan MS, Zhang L, Burnside BA, Finkel KJ, Searleman AC, Selvidge JA, Saager L, Turner MS, Rao S, Bottros M, Hantler C, Jacobsohn E, Evers AS. Anesthesia awareness and the bispectral index. N Engl J Med. 2008 Mar 13;358(11):1097-108. doi: 10.1056/NEJMoa0707361. — View Citation
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Casati A, Fanelli G, Pietropaoli P, Proietti R, Tufano R, Montanini S; Collaborative Italian Study Group on Anaesthesia in Elderly Patients, Danelli G, Nuzzi M, Mentegazzi F, Torri G, Martani C, Spreafico E, Fierro G, Pugliese F, De Cosmo G, Aceto P, Servillo G, Monaco F. Monitoring cerebral oxygen saturation in elderly patients undergoing general abdominal surgery: a prospective cohort study. Eur J Anaesthesiol. 2007 Jan;24(1):59-65. Epub 2006 Jul 7. — View Citation
Chan MT, Cheng BC, Lee TM, Gin T; CODA Trial Group. BIS-guided anesthesia decreases postoperative delirium and cognitive decline. J Neurosurg Anesthesiol. 2013 Jan;25(1):33-42. doi: 10.1097/ANA.0b013e3182712fba. — View Citation
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. — View Citation
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. — View Citation
Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. Erratum in: Lancet 1998 Jun 6;351(9117):1742. — View Citation
Paredes S, Cortínez L, Contreras V, Silbert B. Post-operative cognitive dysfunction at 3 months in adults after non-cardiac surgery: a qualitative systematic review. Acta Anaesthesiol Scand. 2016 Sep;60(8):1043-58. doi: 10.1111/aas.12724. Epub 2016 Mar 29. Review. — View Citation
Radtke FM, Franck M, Lendner J, Krüger S, Wernecke KD, Spies CD. Monitoring depth of anaesthesia in a randomized trial decreases the rate of postoperative delirium but not postoperative cognitive dysfunction. Br J Anaesth. 2013 Jun;110 Suppl 1:i98-105. doi: 10.1093/bja/aet055. Epub 2013 Mar 28. — View Citation
Shahaf DB, Shahaf G, Mehta J, Venkatraghavan L. Intracarotid Etomidate Decreases the Interhemispheric Synchronization in Electroencephalogram (EEG) During the Wada Test. J Neurosurg Anesthesiol. 2016 Oct;28(4):341-6. doi: 10.1097/ANA.0000000000000241. — View Citation
Shahaf G, Fisher T, Aharon-Peretz J, Pratt H. Comprehensive analysis suggests simple processes underlying EEG/ERP - demonstration with the go/no-go paradigm in ADHD. J Neurosci Methods. 2015 Jan 15;239:183-93. doi: 10.1016/j.jneumeth.2014.10.016. Epub 2014 Nov 1. — View Citation
Shahaf G, Pratt H. Thorough specification of the neurophysiologic processes underlying behavior and of their manifestation in EEG - demonstration with the go/no-go task. Front Hum Neurosci. 2013 Jun 24;7:305. doi: 10.3389/fnhum.2013.00305. eCollection 2013. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of depth of anesthesia to post operative delirium | Correlation of depth of anesthesia, as measured by a new EEG based algorithm, to post operative delirium | The diagnosis of delirium is assessed two hours after the operation, when the patient is fully awake, in the post anesthesia care unit (PACU) | |
Primary | Correlation of intra operative EEG changes to early post operative cognitive dysfunction | Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction | The diagnosis of cognitive dysfunction is assessed post operative on day 7 and compared to baseline pre surgery cognitive function. | |
Primary | Correlation of intra operative EEG changes to 45 days post operative cognitive dysfunction | Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction | The diagnosis of cognitive dysfunction is assessed post operative on day 45 and is compared to baseline pre surgery cognitive function. | |
Primary | Correlation of intra operative EEG changes to late post operative cognitive dysfunction | Correlation of EEG changes as measured by a new EEG based algorithm to post operative cognitive dysfunction | The diagnosis of cognitive dysfunction is assessed post operative on day 90 and is compared to baseline pre surgery cognitive function. |
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