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

Chonnam National University

Status: Unknown

Conditions: Anesthesia

Treatments: Device: BIS; Device: ADMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03069456

CNUHH-2015-067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

BIS group

Active Comparator group

Description:

Combined sigmoidal Emax models from the BIS data

Treatment:

Device: BIS

ADMS group

Experimental group

Description:

Combined sigmoidal Emax models from the ADMS data

Treatment:

Device: ADMS