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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01604226
First received: May 21, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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.


Condition
General Anesthesia
Total Intravenous Anesthesia
Bispectral Index Monitoring

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Predicting Bispectral Index Values by Estimated Effect-site Concentration of Propofol and Remifentanil Displayed on the Target-centered Infusion Pump

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Bispectral index value [ Time Frame: every 10 min after anesthetic induction ] [ Designated as safety issue: No ]
    Bispectral index value after anesthetic induction every 10 minutes interval until the end of surgery


Secondary Outcome Measures:
  • Propofol concentration [ Time Frame: every 10 min after anesthetic inducton ] [ Designated as safety issue: No ]
    estimated propofol effect-site concentration displayed in target-centered infusion pump every 10 minutes interval

  • Remifentanil concentration [ Time Frame: every 10 minutes after anesthetic induction ] [ Designated as safety issue: No ]
    estimated remifentanil effect-site concentration displayed in target-centered infusion pump every 10 minutes interval


Estimated Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Gynecologic surgery group
Those undergoing gynecologic laparoscopic surgery with TIVA
Urologic surgery group
Those undergoing urologic surgery with TIVA

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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604226

Contacts
Contact: Sangmin M. Lee, MD, PhD 82-2-3410-0362 sangminm.lee@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-2470 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Won Ho Kim, MD    82-2-3410-2470    bullet57@naver.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Sangmin M. Lee, MD, PhD Samsung Medical Center
Principal Investigator: Won Ho Kim, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01604226     History of Changes
Other Study ID Numbers: 2012-04-094
Study First Received: May 21, 2012
Last Updated: July 8, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
total intravenous anesthesia
Bispectral index monitoring
propofol
remifentanil

Additional relevant MeSH terms:
Propofol
Remifentanil
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014