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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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).
• Устройство new BIS baseline
  Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose.
• Препарат an equivalent dose of saline
  An equivalent dose of saline was given and closed-loop control stared.
• Устройство original BIS baseline
  Drug dosage was adjused under close-loop control based on original BIS baseline.

Первичные конечные точки

• BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control [Срок оценки: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min]

Вторичные конечные точки (7)

• drug consumption [Срок оценки: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min]
• hemodynamic changes during closed-loop control [Срок оценки: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min]
• Postoperative recovery assessment [Срок оценки: time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate]
• VAS [Срок оценки: time from PACU administration to transfer out from PACU.]
• extra analgesic drugs usage [Срок оценки: From transfer into and out PACU]
• occurrance of nausea and vomiting, shivering [Срок оценки: From transfer into and out PACU]
• intraoperative awareness assessment, 15-item quality of recovery (QoR-15) [Срок оценки: From postoperative day 1st to day 7th.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06729892 · GuangzhouGH · 62076253 · 82472110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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