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

• Conditions: Bispectral Index Monitoring; General Anesthesia; Total Intravenous Anesthesia

• Registration Number: NCT01604226
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-22
• Study First Posted: 2012-05-23
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-08
• Last Update Posted: 2014-07-09
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bispectral index value	every 10 min after anesthetic induction	Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery

Secondary Outcome Measures

Name	Time	Method
Propofol concentration	every 10 min after anesthetic inducton	estimated propofol effect-site concentration displayed in target-centered infusion pump every 10 minutes interval
Remifentanil concentration	every 10 minutes after anesthetic induction	estimated remifentanil effect-site concentration displayed in target-centered infusion pump every 10 minutes interval

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of