Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03069456
Recruitment Status : Unknown
Verified February 2017 by Seongwook Jeong, Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Seongwook Jeong, Chonnam National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: BIS Device: ADMS Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using Anesthetic Depth Monitoring for Sedation (ADMS) and Bispectral Index System (BIS)
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: BIS group
Combined sigmoidal Emax models from the BIS data
 Device: BIS
Experimental: ADMS group
Combined sigmoidal Emax models from the ADMS data
 Device: ADMS


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bispectral Index (BIS) [ Time Frame: 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.

  2. Anesthetic depth monitoring for sedation (ADMS) [ Time Frame: 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 :
  1. Adverse events [ Time Frame: visit patients 24 hours after operation. ]
    Observe all adverse events both groups


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069456


Contacts
Layout table for location contacts
Contact: Tae-hee Pyeon, MD +82-10-2705-9901 skybluevus@naver.com

Locations
Layout table for location information
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Korea, Republic of, 519-763
Contact: Chanhong Park    +82-61-379-7598    cnuhpch@naver.com   
Sponsors and Collaborators
Chonnam National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: SEONGWOOK JEONG, MD, PhD. Chonnam National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Seongwook Jeong, professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT03069456    
Other Study ID Numbers: CNUHH-2015-067
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seongwook Jeong, Chonnam National University Hospital:
sevoflurane
Bistpectral index
Anesthetic Depth Monitoring System
population pharmacodynamics