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The investigators want to compare the performance of anesthetic depth monitoring for sedation (ADMS) to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.
Intraoperative awareness under general anesthesia is rare, but it may cause serious psychological sequelae. Anesthetic depth monitoring system based on electroencephalography(EEG) or evoked potential are broadly used methods. Bispectral index (BIS) monitor is most popular anesthetic depth monitoring system. Anesthetic depth monitoring for sedation (ADMS) is developed in Korea as an electroencephalographic monitor for measuring the depth of anesthesia. The investigators want to compare the performance of ADMS to the bispectral index (BIS) as electroencephalographic measures of sevoflurane effect using two combined sigmoidal Emax models via population pharmacodynamic approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS group | Active Comparator | Combined sigmoidal Emax models from the BIS data |
|
| ADMS group | Experimental | Combined sigmoidal Emax models from the ADMS data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIS | Device |
| ||
| ADMS |
| Measure | Description | Time Frame |
|---|---|---|
| Bispectral Index (BIS) | captured BIS data (0~100) from the BIS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min. | Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes |
| Anesthetic depth monitoring for sedation (ADMS) | captured ADMS data (0~100) from the ADMS system after induction of general anesthesia, sevoflurane concentrations will be progressively increased and then decreased over 70 min. | Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Observe all adverse events both groups | visit patients 24 hours after operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tae-hee Pyeon, MD | Contact | +82-10-2705-9901 | skybluevus@naver.com |
| Name | Affiliation | Role |
|---|---|---|
| SEONGWOOK JEONG, MD, PhD. | Chonnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | 519-763 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21892201 | Background | Han DW, Linares-Perdomo OJ, Lee JS, Kim JH, Kern SE. Comparison between cerebral state index and bispectral index as measures of electroencephalographic effects of sevoflurane using combined sigmoidal E(max) model. Acta Pharmacol Sin. 2011 Oct;32(10):1208-14. doi: 10.1038/aps.2011.99. Epub 2011 Sep 5. | |
| 19711188 | Background |
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Combined sigmoidal Emax models from anesthetic depth monitoring for sedation (ADMS) and combined sigmoidal Emax models from bispectral index (BIS) via population pharmacodynamic approach.
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| Kreuer S, Bruhn J, Wilhelm W, Grundmann U, Rensing H, Ziegeler S. Comparative pharmacodynamic modeling of desflurane, sevoflurane and isoflurane. J Clin Monit Comput. 2009 Oct;23(5):299-305. doi: 10.1007/s10877-009-9196-6. Epub 2009 Aug 27. |
| 10443602 | Background | Rehberg B, Bouillon T, Zinserling J, Hoeft A. Comparative pharmacodynamic modeling of the electroencephalography-slowing effect of isoflurane, sevoflurane, and desflurane. Anesthesiology. 1999 Aug;91(2):397-405. doi: 10.1097/00000542-199908000-00013. |