An Early Phase 1 interventional study of Subanesthetic dose of esketamine in Esketamine, sponsored by bo xu. Status unknown. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by bo xu · Early Phase 1, Interventional, and Treatment
The propofol-refentanil program-controlled closed-loop target-controlled infusion system based on NI guidance has been clinically verified. In the case of clinical use of esketamine, the separation anesthesia properties do not affect the accuracy and safety of closed-loop system guidance. However, whether the specific degree of impact can be quantified, and based on quantitative indicators, this model can be better applied to a wider range of clinical actual conditions and different drug administration backgrounds.
The first phase is data collection on the effect of subanesthetic doses of esketamine on NI EEG in closed-loop target-controlled infusion systems for general anesthesia. According to the observation of pre-experiments and the latest literature at home and abroad, foreign studies have confirmed that esketamine does not affect the overall stability of the closed-loop system, and we verified the reliability of this conclusion through pre-experiments. In order to clarify the degree of influence of subanesthetic dose of esketamine on EEG, it is necessary to include a certain amount of esketamine applied to the anesthesia sample of closed-loop target controlled infusion system, through the main observation indicators: the change of EEG NI value after the administration of subanesthetic dose of esketamine during the anesthesia maintenance period, the change of EEG power spectrum, and the quantitative ratio change trend of brain waves (α, β, θ, δ waves). The difference in EEG NI value, power spectrum and dynamic transformation of brain wave increased due to the action of subanesthetic dose of esketamine was obtained, and the difference was quantified by the attribution of data to the degree of change of the actual EEG NI value. According to the preset guidance EEG NI value of the original closed-loop target-controlled infusion drug delivery system 36, the guidance preset value of the closed-loop system of 36+N in the clinical administration scenario of subanesthetic dose of esketamine was reset as the new EEG closed-loop feedback baseline.
The second phase is the validation of the effect of esketamine equivalent to the subanesthetic dose on closed-loop target-controlled infusion general anesthesia based on regulated NI(36+N) feedback.
bo xu is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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The preset EEG value of 36 in closed-loop target-controlled infusion is the baseline value of EEG closed-loop feedback guidance (obtained by the team's previous research results)
Drug: Subanesthetic dose of esketamine
Due to the action of esketamine in closed-loop target-controlled infusion, the EEG preset value of 36+N is the baseline value of the new EEG closed-loop feedback guidance (pre-experiment and literature data, N value is 6-8)
Drug: Subanesthetic dose of esketamine
Both groups were given NI-guided propofol-refentanil dual-channel closed-loop target-controlled infusion under general anesthesia with a laryngeal mask/endotracheal intubation. The experimental group (EEG feedback index 36+N) and the control group (EEG feedback index 36) were intravenously injected esketamine 0.2mg∙kg-1 before anesthesia induction, followed by continuous 5μg∙kg-1∙min-1 infusion to maintain anesthesia for 30 minutes, and the maximum cumulative dose allowed was 100mg. In both groups, the infusion was stopped 30 minutes before the end of surgery.
Also known as: Esketamine hydrochloride injection
EEG value
Differences in EEG values between the two groups based on different feedback baselines
Time frame: From the beginning to the end of the surgery, an average of 4 hours
Anesthesia maintains drug consumption
Two groups of propofol and refentanil consumption
Time frame: From the beginning to the end of the surgery, an average of 4 hours
heart rate
Rate variations and differences throughout the process
Time frame: From the beginning to the end of the surgery, an average of 4 hours
Blood pressure
Changes and differences in blood pressure throughout the process
Time frame: From the beginning to the end of the surgery, an average of 4 hours
pulse
Changes and differences in pulse throughout the process
Time frame: From the beginning to the end of the surgery, an average of 4 hours
No study locations are listed for this record.
Plan to share: No — Data collection is recorded from anesthesia records in the original medical record and uploaded to Data Digital for sharing and management(https://www.bcg.com/publications/2022/how-to-build-a-data-and-digital-strategy)
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esketamine
bo xu