# Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor

> **NIH NIH R44** · PASCALL SYSTEMS, INCORPORATED · 2024 · $399,269

## Abstract

Each day in the United States, over 100,000 patients receive general anesthesia, with about 40% being
aged 60 and above. The current practice of general anesthesia is prone to over-sedating patients, either
due to the lack of brain monitoring or using brain monitors with inaccurate indices. Over-sedation (at 28%
incidence) contributes to Post-Operative Delirium (POD) in elderly population (≥65yrs). Notably, 11% of
these elderly patients suffer from Alzheimer’s Disease and Related Dementias, placing them at an even
higher risk of POD. PASCALL was founded to introduce a novel neuroscience-based EEG-guided
personalized anesthetic management. In our sister grant, AG066325, we proposed and achieved a)
(AG066325 Aim 1,2) the design, development, and FDA 510(k) pre-market clearance of a wireless
anesthetic brain monitor, designated as M0 and b) (AG066325 Aim 3) the development of personalized
algorithms to monitor anesthetic brain state in aging, dementia, and Alzheimer’s disease patients.
In this grant, we aim to fully address the problem by utilizing two recently developed, highly interpretable
brain state markers, the Alpha Modulation Index (AMI) and Slow Frequency Modulation Index (SMI),
along with a patient-specific instantaneous responsiveness algorithm (PSIRA). PSIRA can inform the
anesthesia care giver about the dosing required to maintain a target level of unconsciousness, based on
AMI and SMI indices. In this grant, we focus only on patients receiving propofol, the most widely used
intravenous anesthetic agent. The primary innovations of this project are 1) the highly interpretable
brain state markers and 2) the PSIRA algorithm for unconsciousness management to provide
anesthetic dosage recommendation to minimize POD. We realize this innovation through 4 specific
aims. Aim 1: Demonstrate the technical feasibility of the unconsciousness management system for
intraoperative anesthesia based on AMI/SMI and PSIRA. Aim 2: develop an elderly patient-specific age-
normalized AMI and SMI brain state markers. Aim 3: Fully implement the unconsciousness management
system for general anesthesia with dosage guidance for intravenous propofol on the PASCALL FDA-
cleared M0 monitor. Aim 4: Develop commercialization roadmap for the PSIRA system.
If successful, this effort will bring neuroscience-based precision anesthesia care to millions of older
patients, saving Medicare ~$44,000 per patient per year and eliminating needless suffering including
long-term functional and cognitive disability.

## Key facts

- **NIH application ID:** 11008566
- **Project number:** 1R44AG090247-01
- **Recipient organization:** PASCALL SYSTEMS, INCORPORATED
- **Principal Investigator:** EMERY N BROWN
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $399,269
- **Award type:** 1
- **Project period:** 2024-09-20 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008566

## Citation

> US National Institutes of Health, RePORTER application 11008566, Developing an Elderly Patient-Specific, Accurate, Intuitive and Highly Interpretable System for Unconsciousness Management in General Anesthesia Using PASCALL FDA-Cleared Intraoperative EEG Monitor (1R44AG090247-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/11008566. Licensed CC0.

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