Clinical Trials Logo

Clinical Trial Summary

Burst suppression describes a specific EEG pattern that can generally indicate a too deep general anesthesia. The pathophysiology of anesthetic-induced Burst Suppression may be distinctly different from the pathophysiology of Burst Suppression from other medical causes (e.g., coma, hypothermia, intoxication). Definition criteria of neurologic societies cannot be applied to the classification of Burst Suppression during general anesthesia without adaptation. The lack of a clear definition complicates structured research on anesthetic-induced Burst Suppression EEG in the perioperative setting because of subjective bias. Therefore, a unified agreement on what anesthesia-induced Burst Suppression looks like is crucial to conduct the best possible research. The aim of this study is to formulate the basis for a clear definition of burst suppression EEG that may help to truly understand the significance of this EEG pattern and its relationship to proposed postoperative outcomes such as postoperative delirium, longterm postoperative neurocognitive disorders (PNDs) or increased mortality.


Clinical Trial Description

Intraoperative neuromonitoring is recommended to assess the level of general anesthesia. Additionally, specific intraoperative EEG patterns seem to be associated with PNDs. One of these EEG patterns is the burst suppression EEG. The pattern of waxing and waning activity has been associated with a higher risk factor for postoperative delirium. Commercial patient monitoring systems seem to underestimate the occurrence of Burst Suppression because the detection algorithms may not capture every suppression episode. A visual identification of this pattern is possible, but in the context of anesthesia monitoring, there is no standard definition of a Burst Suppression-EEG in the perioperative setting. Further, it displays unique clinical morphological characteristics. In particular, parameters of the EEG frequency spectrum are remarkably influenced by patients age and anesthetic agents. In order to agree on a definition for Burst Suppression during general anesthesia that will help to standardize Burst Suppression research and to optimize Burst Suppression monitoring, an expert consensus is essential. The planned project aims to pave the way to such a consensus of international expert societies in anesthesiology. Based on EEG data recorded within the framework of previous studies (approved Ethics application dated 20.08.2018 with number 246/18 S & 213/17S, dated 24.05.2017), the investigators will compose a representative data set (overall 50 EEG patterns) consisting of definitive Burst Suppression patterns (positive control), intraoperative EEG without Burst Suppression (negative control) and patterns that indicate different manifestations of a possible Burst Suppression-like pattern. The EEG recordings of this data set will be evaluated by selected international leading experts in EEG-based anesthesia monitoring. Therefore, a software environment (MATLAB) was developed, that allows the international experts to access the data set and score the traces pseudonymously. After the data sets have been scored, the interrater agreement for the single EEG episodes will be statistically analyzed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05508386
Study type Interventional
Source Technical University of Munich
Contact
Status Active, not recruiting
Phase N/A
Start date August 10, 2022
Completion date April 1, 2023

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
Completed NCT01705743 - Minimum Alveolar Concentration of Sevoflurane With Nitrous Oxide Inducing Isoelectric EEG Phase 4
Not yet recruiting NCT01678066 - A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor N/A
Completed NCT00972491 - The Optimal Time to Put Laryngeal Mask Airway in the Mouth Under General Anesthesia N/A
Completed NCT00741507 - Unhealthy Alcohol Drinking and Anesthetic Requirement in Women N/A
Completed NCT01096212 - Efficacy and Safety of Sevofran in Patients Scheduled for Elective Surgery Under General Anesthesia Phase 4
Completed NCT00599066 - Intraoperative M-Entropy Measurements N/A
Completed NCT00532402 - Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas 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