Clinical trial NCT06729892: Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine
Official title: Feasibility of Closed-loop TCI Based on New BIS Baseline in the Presence of Low Dose of Esketamine: a Randomized Controlled Equivalence Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: General Anesthesia With Propofol
Closed-Loop
Keywords: eskemine
close-loop TCI
EEG
depth of anesthesia
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: BIS, % of time within ± 10 units of the BIS setpoint during closed-loop control
timeFrame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
Secondary outcomes:
measure: drug consumption
timeFrame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
measure: hemodynamic changes during closed-loop control
timeFrame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min
measure: Postoperative recovery assessment
timeFrame: time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate
measure: VAS
timeFrame: time from PACU administration to transfer out from PACU.
measure: extra analgesic drugs usage
timeFrame: From transfer into and out PACU
measure: occurrance of nausea and vomiting, shivering
timeFrame: From transfer into and out PACU
measure: intraoperative awareness assessment, 15-item quality of recovery (QoR-15)
timeFrame: From postoperative day 1st to day 7th.
Other outcomes:
Locations:
Study officials:
affiliation: department of anesthesiology, southern theater general hospital of PLA, Guangzhou, China.
name: BO xu, doctor, chief director
role: STUDY_DIRECTOR
References: