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

bo xu

Status and phase: Not yet enrolling; Phase 4

Conditions: General Anesthesia With Propofol; Closed-Loop

Treatments: Device: original BIS baseline; Drug: an equivalent dose of saline; Drug: Esketamine at low dose; Device: new BIS baseline

Study type: Interventional

Funder types: Other

Identifiers

NCT06729892

GuangzhouGH

82472110 (Other Grant/Funding Number)

62076253 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Adjusted-group

Experimental group

Description:

After administering esketamine at low dose , this group adjusted drug dosage under closed-loop control based on the new BIS baseline(50＋N).

Treatment:

Device: new BIS baseline

Drug: Esketamine at low dose

Non-adjusted group

Experimental group

Description:

After administering esketamine at low dose, this group adjusted drug dosage under closed-loop control based on the original BIS baseline(50).

Treatment:

Drug: Esketamine at low dose

Device: original BIS baseline

control group

Placebo Comparator group

Description:

This group adjusted drug dosage under closed-loop control based on the original BIS baseline(50) with an equivalent volume of saline.

Treatment:

Drug: an equivalent dose of saline

Device: original BIS baseline