NCT06729892

Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine

Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: bo xu · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing. As an adjunct to anesthesia, esketamine has been shown to stabilize hemodynamics, reduce opioid use, and reduce postoperative nausea and vomiting. However, due to its specific electroencephalographic excitatory effect, esketmine's clinical use in close-loop system has been limited. The aim of this experiment was to determine the specific impact of esketamine on EEG and thus obtain a new EEG baseline for close-loop system, which can broaden the application of close-loop TCI system in combination with other drugs.

Detailed description

The trial is devided into two phases. In the first phase, we statistically analyzed and calculated the changes of BIS by collecting a sample size of EEG changes after administering low dose of esketamine. We used 0.2 mg/kg as a loading dose and followed by a rate of 5ug/kg/min as esketamine administration and observe the changes in BIS each for 30 minutes. In the second phase, we obtain the BIS quantification value N with the addition of a small dose of esketamine in the first phase and thus obtain a new EEG baseline 50+N. By comparing this EEG-adjusted group with the control group, which run the close-loop system based on original BIS baseline without esketamine, whether the closed-loop system can be better applied based on the new BIS baseline under low dose of esketamine.

Conditions

• General Anesthesia With Propofol
• Closed-Loop

Interventions

Type	Name	Description
DRUG	Esketamine at low dose	Esketamine at low dose was administered(0.2mg· kg-1, 5 ug· kg-1 continuous infusion) and drug dosage was adjusted(propofol and remifentanil) based on the new BIS baseline ( calculated from the pilot study).
DEVICE	new BIS baseline	Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.
DRUG	an equivalent dose of saline	An equivalent dose of saline was given and closed-loop control stared.
DEVICE	original BIS baseline	Drug dosage was adjused under close-loop control based on original BIS baseline.

Timeline

• Start date: 2025-01-20
• Primary completion: 2025-04-30
• Completion: 2025-05-30
• First posted: 2024-12-12
• Last updated: 2025-01-13