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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03069456
• Other study ID #: CNUHH-2015-067
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 27, 2017
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: Chonnam National University Hospital
• Contact: Tae-hee Pyeon, MD
• Phone: +82-10-2705-9901
• Email: skybluevus[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• BIS

• ADMS

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun

Sponsors (1)

Lead Sponsor	Collaborator
Chonnam National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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