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 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.
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.
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.
Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia
Exclusion Criteria:
Those undergoing gynecologic laparoscopic surgery with TIVA
Those undergoing urologic surgery with TIVA
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
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
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
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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