NEUCHATEL, SWITZERLAND -- Masimo (NASDAQ: MASI) announced the findings of a randomized clinical trial published in JAMA Pediatrics in which Dr. Yasuko Nagasaka and colleagues at Tokyo Women’s Medical University demonstrated the ability of electroencephalogram (EEG)-guided anesthesia, using Masimo SedLine® Brain Function Monitoring, to improve anesthesia administration in children undergoing surgery.[1] The researchers found that the use of 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. In turn, the patients experienced a significantly lower rate of pediatric anesthesia emergence delirium, or PAED, which commonly manifests in confusion, agitation, or hallucinations experienced during recovery. When compared with standard practice, children monitored with SedLine also regained consciousness faster and could be safely discharged to the post-anesthesia care unit, or PACU, sooner - time savings that, the researchers noted, may represent additional cost savings. In sum, the researchers found that Masimo SedLine helped to make pediatric anesthesia safer, more efficient, and more cost effective.

Masimo SedLine® Brain Function Monitoring
Masimo SedLine® Brain Function Monitoring
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.

PAED is a frequent and clinically significant complication in pediatric anesthesia,[2] often leading to short-term distress among pediatric patients, parents, and staff. Some of the negative postoperative behaviors can persist for weeks or months.[3] Exposure to commonly used volatile anesthetics like sevoflurane gas has been shown to contribute to PAED.[4] In current standard practice, a fixed amount of sevoflurane, 1.0 minimum alveolar concentration (MAC), is used to maintain pediatric anesthesia, but as the authors note, that may be excessive.[5] Dr. 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, thereby reducing the incidence of PAED.

In the study, children aged 1 to 6 years scheduled for elective surgery involving at least 30 minutes of general anesthesia at the largest children’s hospital in Japan were randomly assigned to an experimental group (n=91), whose anesthesia was guided by Masimo SedLine, or a control group (n=86), whose anesthesia was guided using standard practice, i.e. a fixed sevoflurane dosage of 1.0 MAC. The researchers recorded the amount of sevoflurane exposure for each patient and the time elapsed between important events including intubation, extubation, arrival and discharge from the PACU, and emergence from anesthesia. All patients were assessed for PAED by clinicians blinded to the treatment assignment, using a standard scale.

The researchers found that the incidence of PAED was significantly lower among patients in the SedLine group, affecting 21% of patients vs. 35% of patients in the control group (p=0.04). SedLine group patients were exposed to significantly less sevoflurane, by an average 1.4 MAC hours. They were extubated sooner, by an average of 3.3 minutes, regained consciousness sooner, by an average of 21.4 minutes, and were discharged from the PACU sooner, by an average of 16.5 minutes. The researchers estimated that the reduction in time spent in the OR and PACU, of approximately 20 minutes, may represent a cost savings of $240 to $920 (USD) per case.

The authors concluded, “EEG-guided management of general anesthesia reduced sevoflurane exposure and pediatric anesthesia emergence delirium in children, with faster emergence and shorter post-anesthesia care unit stays. The findings suggest that high concentrations of sevoflurane for induction followed by routine use of 1.0-MAC sevoflurane for maintenance may be excessive.”

They also noted that “with EEG monitoring, parents and guardians may be reassured that health care professionals can make an active effort to reduce and minimize a child’s exposure to anesthetic drugs.”

A similar study in 2022 by Long et al. - one of the first to investigate the impact of EEG-guided anesthesia on children undergoing surgery - found that pediatric patients monitored with SedLine experienced significantly fewer EEG patterns of profound brain inactivity, known as burst suppression. Burst Suppression has also been associated with adverse outcomes, including postoperative delirium.[6]

Yasuko Nagasaka, Professor of Anesthesia at Tokyo Women’s Medical University and the new study’s senior author, commented, “While general anesthesia is necessary for pediatric patients undergoing surgery, parents and guardians may express concerns about their child’s exposure to anesthetic drugs. 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.”

“It is important to recognize,” continued Dr. 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.”

Dean Kurth, MD, attending anesthesiologist at Children’s Hospital of Philadelphia and Professor of Anesthesiology and Critical Care Medicine at the University of Pennsylvania Perelman School of Medicine, added, “This study by Miyasaka et al. confirms the growing realization by pediatric anesthesiologists worldwide that more anesthesia drug is being administered to children than necessary, which has negative consequences. As the authors have shown, SedLine EEG data can help clinicians provide more precise anesthetic drug dosing for each child and improves outcomes.”