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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01604226
Enrollment
100
Registered
2012-05-23
Start date
2012-04-30
Completion date
2014-12-31
Last updated
2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bispectral Index Monitoring, General Anesthesia, Total Intravenous Anesthesia

Keywords

total intravenous anesthesia, Bispectral index monitoring, propofol, remifentanil

Brief 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.

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.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Bispectral index valueevery 10 min after anesthetic inductionBispectral index value after anesthetic induction every 10 minutes interval until the end of surgery

Secondary

MeasureTime frameDescription
Propofol concentrationevery 10 min after anesthetic inductonestimated propofol effect-site concentration displayed in target-centered infusion pump every 10 minutes interval
Remifentanil concentrationevery 10 minutes after anesthetic inductionestimated remifentanil effect-site concentration displayed in target-centered infusion pump every 10 minutes interval

Countries

South Korea

Contacts

Primary ContactSangmin M. Lee, MD, PhD
sangminm.lee@samsung.com82-2-3410-0362
Backup ContactWon Ho Kim, MD
bullet57@naver.com82-2-3410-2470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026