Results from the randomized, controlled trial were published in the Journal of Clinical Anesthesia. In the trial, Dr. Melody H.Y. Long and colleagues from the KK Women’s and Children’s Hospital in Singapore evaluated the ability of electroencephalogram (EEG)-guided anesthesia, using Masimo SedLine brain function monitoring, to reduce the amount of the drug sevoflurane needed to maintain anesthesia in pediatric patients undergoing minor surgery.
The study demonstrated that use of SedLine to guide anesthesia reduced sevoflurane requirements and led to a reduced incidence of burst suppression, which has previously been reported to be associated with postoperative delirium.
Masimo said in a news release that the study enrolled 195 children between age one and six who were scheduled for minor surgery involving general anesthesia induced and maintained using sevoflurane. Children were randomized to either a Masimo SedLine EEG-guided group (100 total) or a standard care group (95).
In the SedLine EEG group, anesthesiologists used the system to help guide the administration of sevoflurane, intending to maintain continuous slow/delta oscillations on the raw EEG and spectrogram, avoiding burst suppression and maintaining a Patient State Index, or PSi – a propriety, processed EEG parameter developed by Masimo – between 25 and 50. In the standard care group, clinicians were blinded to the EEG data.
Researchers found that the EEG group had a concentration of sevoflurane used during induction and maintenance of anesthesia was lower both during induction (4.80% compared to 5.67%) and maintenance (2.23% against 2.38%). The EEG group also had a lower incidence of burst suppression (3.1% vs. 10.9%).
“This is one of the first randomized control trials in the pediatric population showing that EEG-guided anesthesia care utilizing the spectrogram is feasible, and leads to a modest decrease in intraoperative sevoflurane dosage for induction and maintenance in young children aged 1 to 6 years,” the authors concluded. “EEG guidance allows easy visualization of anesthesia-induced changes on the brain in real-time, making it possible to determine which individuals require more (or less) anesthetic to maintain unconsciousness and titrate doses accordingly.”
The researchers say this could be important in children between one and two who appear to require a higher concentration of sevoflurane during surgery, as well as in patients at risk of neurological injury.
Sedline currently holds U.S. indication for use without the PSi parameter.
“We believe the significant reduction in burst suppression noted in the EEG group – less than one-third the amount in the control group – is an important finding. In future studies with larger sample pools, this could demonstrate more profound outcome benefits,” Dr. William C. Wilson, Masimo CMO and SVP of clinical research and medical affairs, said in the release.