Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Esketamine at low dose, new BIS baseline, an equivalent dose of saline, original BIS baseline.
- Who it may be relevant to
- Registry conditions: General Anesthesia With Propofol, Closed-Loop. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Drug 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). - Device new BIS baseline
Close-loop TCI control was under new BIS baseline(calculated from pilot study) in the presence of esketamine at low dose. - Drug an equivalent dose of saline
An equivalent dose of saline was given and closed-loop control stared. - Device original BIS baseline
Drug dosage was adjused under close-loop control based on original BIS baseline.
Primary outcome measures
- 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]
Secondary outcome measures (7)
- drug consumption [Time frame: time of closed-loop control, started from 10 min after esketamine administration and lasted for 50 min]
- 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]
- Postoperative recovery assessment [Time frame: time to BIS>80, time to regain spontaneous breathing, time to answering questions and time to extubate]
- VAS [Time frame: time from PACU administration to transfer out from PACU.]
- extra analgesic drugs usage [Time frame: From transfer into and out PACU]
- occurrance of nausea and vomiting, shivering [Time frame: From transfer into and out PACU]
- intraoperative awareness assessment, 15-item quality of recovery (QoR-15) [Time frame: From postoperative day 1st to day 7th.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06729892 · GuangzhouGH · 62076253 · 82472110