Clinical trial NCT03069456: Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral Index
Official title: Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using Anesthetic Depth Monitoring for Sedation (ADMS) and Bispectral Index System (BIS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: sevoflurane
Bistpectral index
Anesthetic Depth Monitoring System
population pharmacodynamics
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Combined sigmoidal Emax models from anesthetic depth monitoring for sedation (ADMS) and combined sigmoidal Emax models from bispectral index (BIS) via population pharmacodynamic approach.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for an elective operation and postoperative epidural PCA with ASA physical status 1,2,3 who have signed the wrtten informed consent.

Exclusion Criteria:

* preventive anticoagulation treatment
* Significant liver, kidney, coagulation dysfunction
* Clinically significant ECG abnormalities
* administration of psychologic durgs or opioid within 14 days before surgery

Primary outcomes:
measure: Bispectral Index (BIS)
timeFrame: Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes
measure: Anesthetic depth monitoring for sedation (ADMS)
timeFrame: Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: visit patients 24 hours after operation.
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: SEONGWOOK JEONG, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.