Unique ID issued by UMIN | UMIN000038697 |
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Receipt number | R000044106 |
Scientific Title | Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study) |
Date of disclosure of the study information | 2019/12/01 |
Last modified on | 2021/03/29 12:07:06 |
Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Japan |
refractory epilepsy
Anesthesiology | Neurosurgery |
Others
NO
In this study, we analyze the effect of anesthetic agents on electroencephalography in refractory epilepsy patients equipped with chronic intracranial electrode. Our aim of this study is to examine whether it is possible to identify the epileptogenic foci of the patient using this method. Finally, it is expected that refractory epilepsy patients undergoing focal lobectomy can skip intracranial electrode placement.
Efficacy
Diagnostic accuracy to detect epileptogenic foci using the changing rate of average values of Modulation index before and during anesthetic agents administration (propofol and sevoflurane), referred the foci that is clinically determined by the intracranial electrode as true.
-Diagnostic accuracy to detect epileptogenic foci using the changing rate of maximum values of Modulation index before and during anesthetic agents administration (propofol and sevoflurane) and the absolute values in average and maximum of Modulation index, referred the foci that is clinically determined by the intracranial electrode as true.
-To compare the cases meeting ILAE class 3 or lower during the first 6 months to one year after surgery and cases that does not meet this criteria.
-To examine the relationship between sensitivity and specificity and pathological findings based on individual data.
-To examine the relationship between the average and maximum change rate of Modulation index before and during anesthetic administration or the absolute value of Modulation index during anesthetic administration for each electrode and the ratio of KCC2 to NKCC1 in resected specimens.
Observational
Not applicable |
Not applicable |
Male and Female
1) Patients with refractory epilepsy who are scheduled for focal resection after placement of intracranial electrode
2) Patients with obvious abnormalities in MRI in the area expected to show epileptogenicity
3) Patients with ASA-PS (American association of anesthesia physical status) 1-2
4) Patients in NCNP hospital
1) Patients who cannot be used sevoflurane
2) Patients who cannot be used propofol
3) The case an anesthetic other than sevoflurane, propofol, remifentanil, rocuronium is used during EEG measurement
4) Patients with ASA-PS3 or higher
5) Patients with epilepsy surgery not intended for radical surgery
6) The case does not agree with the prescribed bank consent
7) Other persons whom representative of this study consider inappropriate
15
1st name | Keiko |
Middle name | |
Last name | Wada |
National Center of Neurology and Psychiatry
Department of Anesthesiology
187-8551
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
042-341-2712
keikotoki@ncnp.go.jp
1st name | Keiko |
Middle name | |
Last name | Wada |
National Center of Neurology and Psychiatry
Department of Anesthesiology
187-8551
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
042-341-2712
keikotoki@ncnp.go.jp
National Center of Neurology and Psychiatry
Ministry of Education, Culture, Sports, Science and Technology
Japanese Governmental office
National Center of Neurology and Psychiatry
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
042-341-2712
rinri-jimu@ncnp.go.jp
NO
2019 | Year | 12 | Month | 01 | Day |
none
Unpublished
none
17
Primary outcome
1.
Sevoflurane
AUC 0.5863, 95%CI 0.5394-0.6332, P value 0.0003, Specificity when sensitivity is 0.9 0.2371
Propofol
AUC 0.5847, 95%CI 0.5350-0.6343, P value 0.0005,Specificity when sensitivity is 0.9 0.2832
2021 | Year | 03 | Month | 29 | Day |
1) Patients with refractory epilepsy who are scheduled for focal resection after placement of intracranial electrode
2) Patients with obvious abnormalities in MRI in the area expected to show epileptogenicity
3) Patients with ASA-PS (American association of anesthesia physical status) 1-2
4) Patients in NCNP hospital
We studied patients with intractable epilepsy who underwent intracranial electrode placement followed by resection of epileptic focus from October 2018 to March 2020 and met the following inclusion and exclusion criteria. When the patients were scheduled for surgery, the attending neurosurgeons would contact us. After obtaining written informed consent from the study candidates, we confirmed that the patients met the inclusion criteria and did not meet any of the exclusion criteria. If the study subjects were under the age of 18 or determined to be incapable of obtaining consent, consent was obtained from those who could represent the will and interests of the study subject.
General anesthesia and intracranial EEG recording during general anesthesia
Patients took anticonvulsant as usual on the day of second surgery. No other premedication was used.
After admission to the operating room, we started to perform standard monitoring such as percutaneous oximeter saturation, non-invasive blood pressure measurement, and electrocardiogram on the patient. The intracranial EEG was recorded continuously after the patient entered the operating room.
In our institution, we usually use propofol followed by analgesia and muscle relaxation using remifentanil and rocuronium, and intubate tracheal tube after the start of sevoflurane during induction of anesthesia for epilepsy focus resection.
We performed induction of anesthesia as usual, judging the situation of each patient.
Then, the EEGs recorded before the induction of anesthesia when propofol was injected, and when the expiratory sevoflurane concentration reached 1.5-2.0 minimum alveolar concentration (MAC) were taken as an analysis target.
none
Outcomes
1) The primary outcome of this study was diagnostic accuracy to detect epileptogenic foci using the changing rate of average values of MI before and during anesthetic agent administration, referred the foci that is clinically determined by the intracranial electrode as true.
The secondary outcomes of this study were:
2) Diagnostic accuracy to detect epileptogenic foci using the average values of MI, referred the foci that is clinically determined by the intracranial electrode as true.
3) Diagnostic accuracy to detect epileptogenic foci using the changing rate of maximum values of MI before and during anesthetic agent administration, referred the foci that is clinically determined by the intracranial electrode as true.
4) Diagnostic accuracy to detect epileptogenic foci using the maximum values of MI, referred the foci that is clinically determined by the intracranial electrode as true.
5) To compare the cases meeting ILAE class 3 or lower during the first six months to one year after surgery and cases that does not meet this criteria.
6) To examine the relationship between the average and maximum change rate of Modulation index before and during anesthetic administration for each electrode and the ratio of KCC2 to NKCC1 in resected specimens.
7) To examine the relationship between sensitivity and specificity and pathological findings based on individual data.
none
none
Enrolling by invitation
2018 | Year | 08 | Month | 31 | Day |
2018 | Year | 10 | Month | 11 | Day |
2018 | Year | 11 | Month | 13 | Day |
2020 | Year | 12 | Month | 31 | Day |
2021 | Year | 01 | Month | 17 | Day |
2021 | Year | 02 | Month | 23 | Day |
2021 | Year | 03 | Month | 10 | Day |
observational study
2019 | Year | 11 | Month | 27 | Day |
2021 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044106
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