Predicting Bispectral Index Values by Estimated Effect-site Concentration

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01604226
Study type	Observational
Source	Samsung Medical Center
Contact	Sangmin M. Lee, MD, PhD
Phone	82-2-3410-0362
Email	sangminm.lee@samsung.com
Status	Recruiting
Phase	N/A
Start date	April 2012
Completion date	December 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04577430` - Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period	N/A
Completed	`NCT03708692` - Menstrual Cycle Phases on Recovery and Cognitive Function
Recruiting	`NCT03422315` - Population Pharmacokinetics and Clinical Individual Dosage Regimen of Propofoll Injection	N/A
Completed	`NCT02771067` - The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position	N/A
Completed	`NCT05063461` - Evaluation of the Analgesia Nociception Index With Varying Remifentanil Concentrations Under Sevoflurane	N/A
Completed	`NCT03294226` - Comparison of AuraGain With I-gel for Pediatric Patients	N/A
Not yet recruiting	`NCT03643029` - The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy	N/A
Completed	`NCT01945411` - Assessment of Facial Measurements, the Length of Mouth Corner-mandible Angle and Incisors-mandible Angle, for Determining the Proper Sizes of Oropharyngeal Airway	N/A
Not yet recruiting	`NCT01678066` - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor	N/A
Completed	`NCT01705743` - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG	Phase 4
Completed	`NCT00972491` - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia	N/A
Completed	`NCT01096212` - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia	Phase 4
Completed	`NCT00741507` - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women	N/A
Completed	`NCT00532402` - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas	N/A
Completed	`NCT00599066` - Intraoperative M-Entropy Measurements	N/A
Completed	`NCT00468494` - Can Blood Glucose Levels During the Perioperative Period Identify a Population at Risk for Hyperglycemia?	N/A
Recruiting	`NCT00492453` - Spinal Versus General Anesthesia for Laparoscopic Cholecystectomy	N/A
Recruiting	`NCT03745079` - Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Completed	`NCT04094376` - Comparison of Morning Operation and Evening Operation on Postoperative Sleep Quality and Pain Under General Anesthesia	N/A
Enrolling by invitation	`NCT03672734` - Volume and pH of Gastric Contents in Patients Undergoing Gynecologic Laparoscopic Surgery During Emergence From General Anesthesia

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms