NCT06729892|Not Yet RecruitingPhase 4DMC
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Bo Xu
OTHER_GRANT · Bo Xu
interventional
120
0 countries
N/A
Study Start
January 20, 2025
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Primary Completion
April 30, 2025
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Study Completion
May 30, 2025
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 7, 2024
Actual (reported)December 12, 2024
Actual (reported)January 20, 2025
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April 30, 2025
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May 30, 2025
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BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control
% of time within ± 10 units of the BIS setpoint is the most commonly used metric to evaluate performance of closed-loop control.
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
drug consumption
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
hemodynamic changes during closed-loop control
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
Postoperative recovery assessment
time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate
VAS
time from PACU administration to transfer out from PACU.
extra analgesic drugs usage
From transfer into and out PACU
After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).
After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).
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).
Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.
BO xu, doctor, chief director
department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.
First Submitted
December 7, 2024
First Posted
December 12, 2024
Study Start
January 20, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia
This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.
An equivalent dose of saline was given and closed-loop control stared.
Drug dosage was adjused under close-loop control based on original BIS baseline.
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April 30, 2025
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Study Completion
May 30, 2025
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Last Updated
January 13, 2025
Record last verified: 2025-01
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