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

NCT ID: NCT01604226

Last Updated: 2014-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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General Anesthesia Total Intravenous Anesthesia Bispectral Index Monitoring

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Gynecologic surgery group

Those undergoing gynecologic laparoscopic surgery with TIVA

No interventions assigned to this group

Urologic surgery group

Those undergoing urologic surgery with TIVA

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sangmin M. Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangmin M. Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Won Ho Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangmin M. Lee, MD, PhD

Role: CONTACT

82-2-3410-0362

Won Ho Kim, MD

Role: CONTACT

82-2-3410-2470

Facility Contacts

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Won Ho Kim, MD

Role: primary

82-2-3410-2470

Other Identifiers

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2012-04-094

Identifier Type: -

Identifier Source: org_study_id

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