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

NCT06729892 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-13

No results posted yet for this study

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.

Conditions

  • General Anesthesia With Propofol
  • Closed-Loop

Interventions

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.

Sponsors & Collaborators

  • bo xu

    lead OTHER

Principal Investigators

  • BO xu, doctor, chief director · department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-04-30
Completion
2025-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729892 on ClinicalTrials.gov