Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral Index

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using Anesthetic Depth Monitoring for Sedation (ADMS) and Bispectral Index System (BIS)

Conditions
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Anesthesia

Intervention / Treatment
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* Device: BIS
* Device: ADMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BIS group<br>Combined sigmoidal Emax models from the BIS data | Device: BIS<br> <br> |
| Experimental: ADMS group<br>Combined sigmoidal Emax models from the ADMS data | Device: ADMS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Observe all adverse events both groups | visit patients 24 hours after operation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sevoflurane, Bistpectral index, Anesthetic Depth Monitoring System, population pharmacodynamics