Clinical trial
Chief Physician of the Department of Anesthesiology of the Southern Theater General Hospital
Name
Effects of esketamine on EEG
Description
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.
Trial arms
Trial start
2023-07-01
Estimated PCD
2024-10-01
Trial end
2024-10-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
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.
Arms:
Control group, Experimental group
Other names:
Esketamine hydrochloride injection
Size
48
Primary endpoint
EEG value
From the beginning to the end of the surgery, an average of 4 hours
Anesthesia maintains drug consumption
From the beginning to the end of the surgery, an average of 4 hours
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The control group chose the original preset value of 36 as the baseline value of EEG closed-loop feedback guidance (derived from the team's previous research results.The experimental group selected the preset value of 36+N as the baseline value of the new EEG closed-loop feedback guidance (the N value was 6-8 from the pre-experiment).Samples that met the inclusion criteria were randomized and randomly included in the experimental and control groups.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participants were assigned to the management and control groups, and neither group of researchers nor subjects was clear about their group. Data statistical analysts and clinical trial participants maintain independence in their work.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-07-12
1 organization
1 product
1 indication
Organization
Bo XuProduct
EsketamineIndication
Esketamine