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

ConditionsGeneral Anesthesia With PropofolClosed-Loop
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
Sponsorbo xu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI 18~27kg· m-2;

American Society of Anesthesiologists (ASA)physical status I~II;

Undergoing elective laparoscopic surgery.

Disqualifiers

Known or suspected neurological diseases, tumors, stroke, degenerative neurological diseases, epileptic seizures, serious head injuries, cognitive disorders, post-traumatic stress disorder, mental illnesses, severe depression, psychosis, etc.;

Contraindications to ketamine, propofol or remifentanil;

Use of psychotropic drugs within the past 7 days;

History of drug abuse or drug addiction within the past 30 days or during pregnancy;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esketamine at low dose

    Drug

    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).

  • new BIS baseline

    Device

    Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.

  • an equivalent dose of saline

    Drug

    An equivalent dose of saline was given and closed-loop control stared.

  • original BIS baseline

    Device

    Drug dosage was adjused under close-loop control based on original BIS baseline.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Adjusted-groupExperimental treatment 2 interventions
Group B: Non-adjusted groupExperimental treatment 2 interventions
Group C: control groupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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 frame
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min

Secondary outcomes

1

drug consumption

drug consumption of propofol and remifentanil

Time frame
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
2

hemodynamic changes during closed-loop control

Time frame
time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
3

Postoperative recovery assessment

Time frame
time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate
4

VAS

visual analgesic score, one of a most commonly used critieria of pain intensity. VAS ranges from 0\~10, 0\~3 indicates slight or no pain; 4\~6 indicates Moderate pain; 7\~10 indicates severe pain.

Time frame
time from PACU administration to transfer out from PACU.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

bo xu

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: