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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Sangmin M. Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01604226
First Posted: May 23, 2012
Last Update Posted: July 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sangmin M. Lee, Samsung Medical Center
  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 Sangmin M. Lee, Samsung Medical Center:

Primary Outcome Measures:
  • Bispectral index value [ Time Frame: every 10 min after anesthetic induction ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sangmin M. Lee, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01604226     History of Changes
Other Study ID Numbers: 2012-04-094
First Submitted: May 21, 2012
First Posted: May 23, 2012
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Sangmin M. Lee, Samsung Medical Center:
total intravenous anesthesia
Bispectral index monitoring
propofol
remifentanil

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


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