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

NCT01604226 | Unknown DMC

• 1 other identifier: 2012-04-094
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthesia; Total Intravenous Anesthesia; Bispectral Index Monitoring

Keywords

total intravenous anesthesia; Bispectral index monitoring; propofol; remifentanil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Propofol concentration

  every 10 min after anesthetic inducton

• Remifentanil concentration

  every 10 minutes after anesthetic induction

Study Arms (2)

Gynecologic surgery group

Those undergoing gynecologic laparoscopic surgery with TIVA

Urologic surgery group

Those undergoing urologic surgery with TIVA

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Those with unstable hemodynamics
• Those who can not undergo Bispectral index monitoring
• Those with previous history of stroke

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Study Officials

• Sangmin M. Lee, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Won Ho Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangmin M. Lee, MD, PhD

CONTACT

82-2-3410-0362; sangminm.lee@samsung.com

Won Ho Kim, MD

CONTACT

82-2-3410-2470; bullet57@naver.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

KR (1)