UnknownEarly Phase 1ketamine
Effect of Subanesthetic Dose Esketamine on Propofol-refentanil Closed-loop Targeted Controlled Infusion
Sponsored by bo xu
NCT ID
NCT05943028
Target Enrollment
48 participants
Start Date
2023-07-01
Est. Completion
2024-10-01
About This Study
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.
Conditions Studied
Interventions
- •Subanesthetic dose of esketamine
Eligibility
Age:18 Years - 55 Years
Healthy Volunteers:No
View full 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.