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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Won Ho Kim, MD; Phone Number: 82-2-3410-2470; Email: bullet57@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Won Ho Kim, MD; Phone Number: 82-2-3410-2470; Email: bullet57@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Gynecologic surgery group; Those undergoing gynecologic laparoscopic surgery with TIVA
Urologic surgery group; Those undergoing urologic surgery with TIVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral index value	Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery	every 10 min after anesthetic induction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Won Ho Kim, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 22, 2012
• First Posted (Estimate): May 23, 2012

Study Record Updates

• Last Update Posted (Estimate): July 9, 2014
• Last Update Submitted That Met QC Criteria: July 8, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: propofol; remifentanil; total intravenous anesthesia; Bispectral index monitoring
• Other Study ID Numbers: 2012-04-094