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

Not Applicable

• Conditions: Anesthesia
• Interventions: Device: BIS; Device: ADMS

• Registration Number: NCT03069456
• Lead Sponsor: Chonnam National University Hospital

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.

Study Timeline

• Study Start: 2016-04
• Status Verified: 2017-02
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2017-06
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BIS group	BIS	Combined sigmoidal Emax models from the BIS data
ADMS group	ADMS	Combined sigmoidal Emax models from the ADMS data

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Adverse events	visit patients 24 hours after operation.	Observe all adverse events both groups

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of