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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01604226
• Other study ID #: 2012-04-094
• Status: Recruiting
• Phase: N/A
• First received: May 21, 2012
• Last updated: July 8, 2014
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Samsung Medical Center
• Contact: Sangmin M. Lee, MD, PhD
• Phone: 82-2-3410-0362
• Email: sangminm.lee[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bispectral Index Monitoring
• General Anesthesia
• Total Intravenous Anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bispectral index value	Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery	every 10 min after anesthetic induction	No
Secondary	Propofol concentration	estimated propofol effect-site concentration displayed in target-centered infusion pump every 10 minutes interval	every 10 min after anesthetic inducton	No
Secondary	Remifentanil concentration	estimated remifentanil effect-site concentration displayed in target-centered infusion pump every 10 minutes interval	every 10 minutes after anesthetic induction	No