Masimo (Nasdaq: MASI) announced study findings supporting the use of its SedLine brain function monitoring in children.
Dr. Yasuko Nagasaka and colleagues at Tokyo Women’s Medical University conducted the randomized clinical trial. It demonstrated the ability of electroencephalogram (EEG)-guided anesthesia using SedLine to improve anesthesia administration in children undergoing surgery. Investigators published their findings in JAMA Pediatrics.
According to a news release, the researchers found that using SedLine led to a significant reduction in the amount of a commonly used inhalation anesthetic (sevoflurane) needed to maintain anesthesia in pediatric patients, reducing their exposure to the drug. This led to a significantly lower rate of pediatric anesthesia emergence delirium, or PAED. This commonly manifests in confusion, agitation, or hallucinations experienced during recovery.
When compared with standard practice, children monitored with SedLine also regained consciousness faster. This led to sooner safe discharge to the post-anesthesia care unit, or PACU. These time savings may also represent additional cost savings, the researchers say.
Children monitored with SedLine were exposed to an average of 1.4 MAC hours less sevoflurane and had a 14% lower incidence rate of PAED. On average, they regained consciousness 53% sooner and were discharged from the PACU 48% sooner. The time saved led to an estimated cost savings of $240 to $920 per patient.
“While general anesthesia is necessary for pediatric patients undergoing surgery, parents and guardians may express concerns about their child’s exposure to anesthetic drugs,” Nagasaka said. “We can now offer reassurance by explaining that modern medical technologies, such as EEG-guided anesthesia care, help minimize anesthetic exposure, potentially reducing the incidence of pediatric emergence delirium (PAED) and supporting earlier awakening and recovery from unconsciousness.”
More about the Masimo study
Nagasaka and her team hypothesized that by using bilateral EEG — in particular, the waveforms and multitaper density spectral array (DSA) spectrograms displayed by Masimo SedLine — to guide sevoflurane titration, the amount needed to induce and maintain appropriate sedation could be reduced. This thereby would reduce the incidence of PAED.
The study looked at children between one and six years old scheduled for elective surgery involving at least 30 minutes of general anesthesia. Investigators randomly assigned 91 to an experimental group guided by SedLine. The control group had 86 participants receiving anesthesia guided by standard practice.
PAED occurrance came in significantly lower in the SedLine group, affecting 21% of patients vs. 35% in the control. SedLine patients had significantly less exposure to sevofluran and were extubated sooner by an average of 3.3 minutes. They also regained consciousness sooner, by an average of 21.4 minutes. Discharge from the PACU was, on average, 16.5 minutes sooner.
“It is important to recognize,” added Nagasaka, “that increasing the depth of anesthesia is relatively easy to learn. On the other hand, developing the confidence and skill to safely reduce anesthesia requires deeper understanding. Our results may offer a great step forward towards the improvement of our common practice, which may lead to the development of guidelines for EEG monitoring in pediatric areas to eventually mandate EEG monitoring during general anesthesia in the future. But comprehensive training in EEG-guided anesthesia should be considered a critical next step for the entire anesthesia community.”
