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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01604226
Other study ID # 2012-04-094
Secondary ID
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


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
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