Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06729892

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 18~27kg· m-2;
  • American Society of Anesthesiologists (ASA)physical status I~II;
  • Undergoing elective laparoscopic surgery.

Exclusion criteria

  • 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;
  • Current participation in any other studies involving other drugs or devices.

Treatment and study plan

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.

Primary outcomes

  1. BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control

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

    % of time within ± 10 units of the BIS setpoint is the most commonly used metric to evaluate performance of closed-loop control.

Secondary outcomes

  1. drug consumption

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

    drug consumption of propofol and remifentanil

  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

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

    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.

  5. extra analgesic drugs usage

    Time frame: From transfer into and out PACU

  6. occurrance of nausea and vomiting, shivering

    Time frame: From transfer into and out PACU

  7. intraoperative awareness assessment, 15-item quality of recovery (QoR-15)

    Time frame: From postoperative day 1st to day 7th.

    Intraoperative awareness is assessed by modified Brice questionnaire; This questionnaire consists of 5 questions. Level of Intraoperative awareness ranges from 0~5. The QoR-15 questionnaire is composed of 15 questions, including physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain(2 items). The higher of the QoR-15 scores, the better of the quality of recovery after surgery (range is 0 to 150 points).

Study contacts

Contact information is provided by the study sponsor or research team.

bo Xu, Doctor, chief director.

CONTACT

[email protected]

86 + 13802738125

xiaoshan Li, postgraduate

CONTACT

[email protected]

86 + 17820686302

Sponsors and collaborators

Lead sponsor

bo xu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.