Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine
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
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
Treatments tested in this trial
- Esketamine at low dose
- new BIS baseline
- an equivalent dose of saline
- original BIS baseline
Treatment groups
120 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
bo xu
Lead sponsor
Guangzhou General Hospital of Guangzhou Military Command
Sponsor institution
Source ClinicalTrials.gov