Predicting Bispectral Index Values by Estimated Effect-site Concentration of Propofol and Remifentanil Displayed on the Target-centered Infusion Pump
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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 2012 |
| Estimated Primary Completion Date: | December 2012 (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 |
Those undergoing gynecologic or urologic surgery with general anesthesia with total intravenous anesthesia
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| 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 |
| 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 | |
| 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: | May 22, 2012 |
| 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 May 16, 2013