CClinicalTrials.gg
Status unknownNCT01604226Updated Jul 9, 2014

Predicting Bispectral Index Values by Estimated Effect-site Concentration of Propofol and Remifentanil Displayed on the Target-centered Infusion Pump

An observational study in General Anesthesia, Total Intravenous Anesthesia and Bispectral Index Monitoring, sponsored by Samsung Medical Center. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-09.

Sponsored by Samsung Medical Center · Observational

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
100
Ages
20 Years to 80 Years
Sex
All
01

Study summary

The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, the investigators postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

Read the detailed description

Total intravenous anesthesia is commonly performed with propofol and remifentanil now-a-days. The combination of these two drugs can achieve the rapid loss of consciousness and analgesia,as the onset and recovery time of these two drugs are very fast within one to three minutes. However, the problem of intraoperative awareness necessitate the monitoring of anesthetic depth, which is commonly performed with Bispectral index (BIS). BIS is a display of number from zero to one hundred which quantify the degree of sedation and hypnosis by anesthetics by analyzing the electroencephalogram. However, it is limited in neurosurgery in which the surgical field is near the forehead where the BIS probe is attached. Furthermore, it is also limited in surgery with prone position. The BIS is influenced by multiple parameters, such as age,gender, body weight, height, muscle relaxants, hepatic function, co-administered drugs, surgical stimulation, but is thought to be influenced mainly by propofol and remifentanil infusion dose. As such, we postulate that the BIS value could be predicted by the estimated effects-site concentration of propofol and remifentanil, and try to establish a multiple linear regression model for predicting BIS value.

02

Conditions studied

  • General Anesthesia
  • Total Intravenous Anesthesia
  • Bispectral Index Monitoring

Keywords

  • total intravenous anesthesia
  • Bispectral index monitoring
  • propofol
  • remifentanil
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia

Inclusion criteria

  • Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia
  • Adult patients with more than 20 yrs.
  • American Society of Anesthesiologists Class I or II.

Exclusion criteria

Exclusion Criteria:

  • Those with unstable hemodynamics
  • Those who can not undergo Bispectral index monitoring
  • Those with previous history of stroke
05

Study design

Time perspective
Prospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • Gynecologic surgery group

    Those undergoing gynecologic laparoscopic surgery with TIVA

  • Urologic surgery group

    Those undergoing urologic surgery with TIVA

06

What researchers measure

Primary outcomes

  1. Bispectral index value

    Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery

    Time frame: every 10 min after anesthetic induction

Secondary outcomes

  1. Propofol concentration

    estimated propofol effect-site concentration displayed in target-centered infusion pump every 10 minutes interval

    Time frame: every 10 min after anesthetic inducton

  2. Remifentanil concentration

    estimated remifentanil effect-site concentration displayed in target-centered infusion pump every 10 minutes interval

    Time frame: every 10 minutes after anesthetic induction

07

Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01604226
Lead sponsor
Samsung Medical Center
Responsible party
Sangmin M. Lee (Professor, Samsung Medical Center) — Principal investigator
First posted
May 23, 2012
Start date
Apr 2012
Primary completion
Dec 2014 (estimated)
Completion
Dec 2014 (estimated)
Last update
Jul 9, 2014

Study contacts

Sangmin M. Lee, MD, PhD
Contact
sangminm.lee@samsung.com
82-2-3410-0362
Won Ho Kim, MD
Contact
bullet57@naver.com
82-2-3410-2470
Sangmin M. Lee, MD, PhD
principal investigator · Samsung Medical Center
Won Ho Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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