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

NCT03069456 | Unknown

• 1 other identifier: CNUHH-2015-067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Adverse events

  visit patients 24 hours after operation.

Study Arms (2)

BIS group

ACTIVE COMPARATOR

Combined sigmoidal Emax models from the BIS data

Device: BIS

ADMS group

EXPERIMENTAL

Combined sigmoidal Emax models from the ADMS data

Device: ADMS

Interventions

BIS DEVICE

BIS group

ADMS DEVICE

ADMS group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• preventive anticoagulation treatment
• Significant liver, kidney, coagulation dysfunction
• Clinically significant ECG abnormalities
• administration of psychologic durgs or opioid within 14 days before surgery

Sponsors & Collaborators

• Chonnam National University Hospital: lead

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, 519-763, South Korea

RECRUITING

Related 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. Epub 2011 Sep 5.

  PMID: 21892201 BACKGROUND

• 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. Epub 2009 Aug 27.

  PMID: 19711188 BACKGROUND

• 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. doi: 10.1097/00000542-199908000-00013.

  PMID: 10443602 BACKGROUND

Study Officials

• SEONGWOOK JEONG, MD, PhD.

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tae-hee Pyeon, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Combined sigmoidal Emax models from anesthetic depth monitoring for sedation (ADMS) and combined sigmoidal Emax models from bispectral index (BIS) via population pharmacodynamic approach.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 3, 2017
• Study Start: April 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)