Effect of Subanesthetic Dose Esketamine on Propofol-refentanil Closed-loop Targeted Controlled Infusion

Esketamine Clinical Trial

Official title:

Chief Physician of the Department of Anesthesiology of the Southern Theater General Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05943028
• Other study ID #: Effects of esketamine on EEG
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2023
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: Bo Xu, professor
• Phone: +8613802738125
• Email: xubo333[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 1. Patients undergoing laparoscopic general anesthesia surgery with anesthesia duration > 60min, 2.18~55 years old, 3.BMI=18.5kg/m2, 4. ASA Class I~II

Exclusion Criteria:

• Exclude patients with any of the following criteria:

1. Contraindications to esketamine, propofol or refentanil;

2. Allergic reactions to egg/soy products; Hypersensitivity to fentanyl analogues;

3. Known/suspected neurological diseases, tumors, strokes, neurodegenerative diseases, severe head injuries, seizures, previous EEG abnormalities, cognitive deficits, acquired scalp/skull abnormalities, psychiatric diseases, severe depression, post-traumatic stress disorder, psychosis;

4. Taking psychotropic drugs within the past 7 days,

5. History of substance abuse/abuse or pregnancy in the past 30 days;

6. Currently involved in any other research involving drugs or devices.

Related Conditions & MeSH terms

• Esketamine

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
bo xu

References & Publications (2)

Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13. — View Citation

Napoleone G, van Heusden K, Cooke E, West N, Gorges M, Dumont GA, Ansermino JM, Merchant RN. The Effect of Low-Dose Intraoperative Ketamine on Closed-Loop-Controlled General Anesthesia: A Randomized Controlled Equivalence Trial. Anesth Analg. 2021 Nov 1;133(5):1215-1224. doi: 10.1213/ANE.0000000000005372. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG value	Differences in EEG values between the two groups based on different feedback baselines	From the beginning to the end of the surgery, an average of 4 hours
Primary	Anesthesia maintains drug consumption	Two groups of propofol and refentanil consumption	From the beginning to the end of the surgery, an average of 4 hours
Secondary	heart rate	Rate variations and differences throughout the process	From the beginning to the end of the surgery, an average of 4 hours
Secondary	Blood pressure	Changes and differences in blood pressure throughout the process	From the beginning to the end of the surgery, an average of 4 hours
Secondary	pulse	Changes and differences in pulse throughout the process	From the beginning to the end of the surgery, an average of 4 hours