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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03069456

Enrollment

Registered

2017-03-03

Start date

2016-04-30

Completion date

2017-12-31

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

sevoflurane, Bistpectral index, Anesthetic Depth Monitoring System, population pharmacodynamics

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.

Interventions

DEVICEBIS

DEVICEADMS

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Bispectral Index (BIS)	Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes	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.
Anesthetic depth monitoring for sedation (ADMS)	Data capture will be started 45 minutes after induction of general anesthesia for 70 minutes	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.

Secondary

Measure	Time frame	Description
Adverse events	visit patients 24 hours after operation.	Observe all adverse events both groups

Countries

South Korea

Contacts

Primary ContactTae-hee Pyeon, MD

skybluevus@naver.com+82-10-2705-9901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026