Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04481347
Status:
RECRUITING
Last Update Posted:
2023-10-25
First Post:
2020-06-23
Brief Title:
Relationship Between Sleep EEG Intraoperative EEG and Postoperative Cognitive Dysfunction
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Relationship Between Sleep EEG Intraoperative EEG and Postoperative Cognitive Dysfunction
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOMEDYSPO
Brief Summary:
The challenge of new recommendations and better adapted practices is pushing to operate patients who are getting older and more fragile In this context there is an inevitable increase in the risks associated with care and in particular perioperative neurological complications of which postoperative cognitive dysfunction POCD is the most common
The interest of perioperative cerebral monitoring and in particular electroencephalography EEG to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue
From the literature and preliminary results obtained in our clinical research unit it appears that there is also a relationship between certain characteristics of the peroperative EEG signal strength and burst suppression and the occurrence of postoperative cognitive dysfunction PCOD
In this context quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility To our knowledge there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD
The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction
The interest of perioperative cerebral monitoring and in particular electroencephalography EEG to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue
From the literature and preliminary results obtained in our clinical research unit it appears that there is also a relationship between certain characteristics of the peroperative EEG signal strength and burst suppression and the occurrence of postoperative cognitive dysfunction PCOD
In this context quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility To our knowledge there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD
The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction
Detailed Description:
The interest of perioperative brain monitoring to reduce neurological and cognitive damage in surgery has been the subject of much research and corresponds to a crucial issue
The notion of quantitative EEG covers all the electrical signal processing techniques fast Fourier transformation evoked potentials EEG mapping etc made possible through the digitization of EEG data and the development of software to process these signals In this context EEG-derived indices have been set up to monitor hypnosis during general anesthesia Between 0 deep hypnosis and 100 awakening the Bispectral Index BIS integrates in its calculation the percentage of fast waves the degree of wave synchronization and the periods of EEG suppression or Burst suppression and allows an adaptation of the dosage of anesthetic products according to its value
Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative delirium by reducing the burst suppression pattern
Pre-operative cognitive status assessment
The investigators observe a great delay in the means implemented to have an objective evaluation of cognitive disorders in preoperative care
One of the pitfalls of our anesthetist specialty is the lack of continuity of medical care in the perioperative period
The geriatric evaluation including a MMSE mental mini state examination and a MoCA Montreal cognitive assessment is performed only occasionally
Interest of the resting pre-operative EEG
Sleep EEG analysis is already used in cognitive studies Slow Wave Activity SWA is a parameter known to be inversely correlated with chronological age and lowered more significantly in the context of cognitive dysfunction
The power of spindles or sleep spindles and particularly fast spindles have been shown to be potentially predictive of poor cognitive development in patients already showing symptoms Mild Cognitive Impairment
It is likely that per operative susceptibility to Burst suppression and the appearance of postoperative cognitive dysfunction are linked to a set of per operative factors anesthesia surgery inflammation pain but also preoperative factors cognitive state physiological age and cerebral fragility
The investigators hypothesize that there is an association between preoperative resting EEG abnormalities and the risk of postoperative cognitive dysfunction
The goal of this observational clinical study is to assess the fragility of a patient under general anesthesia and based on the perioperative quantitative analysis EEG Thus this project should help specialists in perioperative medicine to identify patients at risk of cognitive dysfunction and could lead to proposing strategies for its prevention
Measures are based on neuro-psychological tests Montreal cognitive assesment -MoCA and EEG signal and subfrequency power spectral densities including alpha band as well as the amount of Propofol each measured for EEG periods where SEF 95 8-13Hz
Analysis includes the characteristics of the preoperative sleep EEG SWA fast spindles
Experimental design This is a single-center observational prospective study
Population concerned
Patients eligible for interventional neuroradiology or surgery performed under General Anesthesia are selected to participate in this prospective observational single-center routine care study Patients will be included if they received for a non-urgent scheduled procedure
Patients over 18 years of age are eligible to participate in this protocol During the anesthesia consultation they will be given a hand-delivered letter of information on the objectives and the course of the study Their non-opposition to participating in this study will be collected at the latest during the pre-anesthetic visit on the eve of the operation after a period of reflection
The protocol will start the day before the intervention The interventions will be performed under general anaesthesia The protocol does not interact with the care procedure All the measures are obtained non-invasively
The day before the procedure performance of a sleep EEG DREEM and a MoCA test On the day of the procedure monitoring of the depth of anesthesia using the quantitative EEG Sedline Masimo ensures continuous recording of intraoperative EEG data Postoperatively the same investigator performs MoCA at Day1 Day2 and Day5 A sleep EEG DREEM is performed at Day2 and Day5 if the patient is still hospitalized
During their general anesthesia all patients routine monitoring will consist in collecting the following parameters electrocardiogram pulsated oxygen saturation endtidal CO2 respiratory rate tidal volume and neuromuscular function
For all patients whatever the comorbidities anesthesia induction will be performed using a target-controlled infusion Orchestra Base Primea - Fresenius Kabi France
No additional additional examination will be performed The anesthetic strategy is decided by the anesthetist in charge of the procedure
The doctor in charge of the study collecting the data does not interfere at any time in the management of the patient The measurements cannot influence the prescribing physician since at this stage the data are not yet analysed and available
Number of selected subjects Assuming an incidence of DCPO of 30 with power at 80 and alpha risk at 5 it is necessary to include 100 patients to demonstrate an area under the ROC curve of 80 with a confidence interval width of 01
Statistics
Continuous data will be expressed in median interquartile and qualitative data in n Categorical variables will be compared by Mann-Whitney test and continuous variables by Wilcoxon test
In this study the primary endpoint was the occurrence of post-operative cognitive dysfunction defined as a decrease in MoCA score of more than 4 points between preoperative and postoperative periods worst value of the score measured at D1 D2 and D5 The main exposure is the quantitative score obtained from the analysis of the pre-operative sleep EEG
The ability of the various parameters of interest of the preoperative sleep EEG to predict the occurrence of DCPO will be estimated by constructing an ROC curve The area of these ROC curves will be measured and the corresponding 95 confidence interval estimated The areas under the ROC curve of the different parameters will be compared by DeLong test A uni- and then multivariate analysis will be performed to identify the clinical parameters associated with the occurrence of a DCPO The possible added value of the sleep EEG parameters on the clinical parameters will be evaluated by reclassification techniques
The statistical analysis will be carried out using the statistical analysis software R The R Foundation Vienna Austria
The notion of quantitative EEG covers all the electrical signal processing techniques fast Fourier transformation evoked potentials EEG mapping etc made possible through the digitization of EEG data and the development of software to process these signals In this context EEG-derived indices have been set up to monitor hypnosis during general anesthesia Between 0 deep hypnosis and 100 awakening the Bispectral Index BIS integrates in its calculation the percentage of fast waves the degree of wave synchronization and the periods of EEG suppression or Burst suppression and allows an adaptation of the dosage of anesthetic products according to its value
Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative delirium by reducing the burst suppression pattern
Pre-operative cognitive status assessment
The investigators observe a great delay in the means implemented to have an objective evaluation of cognitive disorders in preoperative care
One of the pitfalls of our anesthetist specialty is the lack of continuity of medical care in the perioperative period
The geriatric evaluation including a MMSE mental mini state examination and a MoCA Montreal cognitive assessment is performed only occasionally
Interest of the resting pre-operative EEG
Sleep EEG analysis is already used in cognitive studies Slow Wave Activity SWA is a parameter known to be inversely correlated with chronological age and lowered more significantly in the context of cognitive dysfunction
The power of spindles or sleep spindles and particularly fast spindles have been shown to be potentially predictive of poor cognitive development in patients already showing symptoms Mild Cognitive Impairment
It is likely that per operative susceptibility to Burst suppression and the appearance of postoperative cognitive dysfunction are linked to a set of per operative factors anesthesia surgery inflammation pain but also preoperative factors cognitive state physiological age and cerebral fragility
The investigators hypothesize that there is an association between preoperative resting EEG abnormalities and the risk of postoperative cognitive dysfunction
The goal of this observational clinical study is to assess the fragility of a patient under general anesthesia and based on the perioperative quantitative analysis EEG Thus this project should help specialists in perioperative medicine to identify patients at risk of cognitive dysfunction and could lead to proposing strategies for its prevention
Measures are based on neuro-psychological tests Montreal cognitive assesment -MoCA and EEG signal and subfrequency power spectral densities including alpha band as well as the amount of Propofol each measured for EEG periods where SEF 95 8-13Hz
Analysis includes the characteristics of the preoperative sleep EEG SWA fast spindles
Experimental design This is a single-center observational prospective study
Population concerned
Patients eligible for interventional neuroradiology or surgery performed under General Anesthesia are selected to participate in this prospective observational single-center routine care study Patients will be included if they received for a non-urgent scheduled procedure
Patients over 18 years of age are eligible to participate in this protocol During the anesthesia consultation they will be given a hand-delivered letter of information on the objectives and the course of the study Their non-opposition to participating in this study will be collected at the latest during the pre-anesthetic visit on the eve of the operation after a period of reflection
The protocol will start the day before the intervention The interventions will be performed under general anaesthesia The protocol does not interact with the care procedure All the measures are obtained non-invasively
The day before the procedure performance of a sleep EEG DREEM and a MoCA test On the day of the procedure monitoring of the depth of anesthesia using the quantitative EEG Sedline Masimo ensures continuous recording of intraoperative EEG data Postoperatively the same investigator performs MoCA at Day1 Day2 and Day5 A sleep EEG DREEM is performed at Day2 and Day5 if the patient is still hospitalized
During their general anesthesia all patients routine monitoring will consist in collecting the following parameters electrocardiogram pulsated oxygen saturation endtidal CO2 respiratory rate tidal volume and neuromuscular function
For all patients whatever the comorbidities anesthesia induction will be performed using a target-controlled infusion Orchestra Base Primea - Fresenius Kabi France
No additional additional examination will be performed The anesthetic strategy is decided by the anesthetist in charge of the procedure
The doctor in charge of the study collecting the data does not interfere at any time in the management of the patient The measurements cannot influence the prescribing physician since at this stage the data are not yet analysed and available
Number of selected subjects Assuming an incidence of DCPO of 30 with power at 80 and alpha risk at 5 it is necessary to include 100 patients to demonstrate an area under the ROC curve of 80 with a confidence interval width of 01
Statistics
Continuous data will be expressed in median interquartile and qualitative data in n Categorical variables will be compared by Mann-Whitney test and continuous variables by Wilcoxon test
In this study the primary endpoint was the occurrence of post-operative cognitive dysfunction defined as a decrease in MoCA score of more than 4 points between preoperative and postoperative periods worst value of the score measured at D1 D2 and D5 The main exposure is the quantitative score obtained from the analysis of the pre-operative sleep EEG
The ability of the various parameters of interest of the preoperative sleep EEG to predict the occurrence of DCPO will be estimated by constructing an ROC curve The area of these ROC curves will be measured and the corresponding 95 confidence interval estimated The areas under the ROC curve of the different parameters will be compared by DeLong test A uni- and then multivariate analysis will be performed to identify the clinical parameters associated with the occurrence of a DCPO The possible added value of the sleep EEG parameters on the clinical parameters will be evaluated by reclassification techniques
The statistical analysis will be carried out using the statistical analysis software R The R Foundation Vienna Austria
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A03206-51 | OTHER | IDRCB | None |