Feasibility of Closed-Loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine: A Randomized Controlled Equivalence Trial.
Xiaoshan Li, Shengchao Li, Chanyan Xu, Huan He, Weidong Shao, Shuteng Zhan, Bo Xu
Drug Design, Development and Therapy 2025 DOI: 10.2147/DDDT.S508264 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 111 |
| Population | Patients undergoing propofol-remifentanil general anesthesia |
| Interventions | Esketamine Propofol Remifentanil |
| Dose | 0.2 mg kg-1 bolus, 5 μg kg-1 min-1 infusion for 30 min |
| Topics | Esketamine |
| Keywords | Closed-loop controlled system Depth of anesthesia New bis baseline Patient monitoring Brain-Computer Interfaces EEG Neurological monitoring Closed-loop systems Targeted therapy Adaptive |
| Citations | 3 |
| Key findings | A closed-loop TCI system using an adjusted BIS baseline after low-dose esketamine administration performed equivalently to standard systems and reduced propofol consumption. |
Abstract
This research aimed to quantify the impact of low dose of esketamine on BIS and validate the feasibility of closed-loop TCI system based on the new BIS baseline with low dose of esketamine. This study consisted of two phases. The first phase was to quantify the impact of a low dose of esketamine (0.2mg kg-1 bolus, 5μg kg-1 min-1 infusion for 30min) on BIS and establish a new BIS baseline for propofol-remifentanil general anesthesia. The second phase was used to validate the feasibility of closed-loop TCI system based on the new BIS baseline. One hundred and eleven patients were randomly and equally assigned to three groups (group A: adjusted group, group N: non-adjusted group and group C: control group). After administering a low dose of esketamine, group A adjusted drug dosage based on new BIS baseline, while group N based on the original BIS baseline of 50, group C adjusted drug doses based on the original baseline of 50 without esketamine. Main outcome was controller performance (% time within±10units of the BIS setpoint). Secondary outcomes were drug consumption, occurrence of adverse events such as intraoperative awareness, treatment of hemodynamic changes and postoperative recovery quality. In the first phase, after administering a low dose of esketamine, the BIS increased from 49.9±4.5 to 59.6±6.0, p<0.01. In the second phase, the controller performance in group A and N were within the range of high-performance systems, and both were equivalent with control group. Group A showed lower consumption of propofol compared to control group (5.58±1.12 vs 6.69±1.36 (mg·kg-1·h-1), p<0.05). There was no difference in adverse events such as intraoperative awareness, recovery assessment and postoperative VAS, PONV and shivering, QoR-15 assessment after adjusting the BIS baseline. It is feasible to operate the closed-loop TCI system based on the adjusted BIS baseline in the presence of low dose of esketamine.
Comparable studies
Other randomized controlled trials on esketamine, most cited first.