Anesthesia, Intravenous, Laparoscopy
Conditions
Brief summary
The objective is to evaluate the efficacy and safety of BT-KTM-I(Esketamine Hydrochloride Injection produced by Chengdu Brilliant Pharmaceutical Co., Ltd.) for general anesthesia, using the Originator drug Ketanest®S(Esketamine Hydrochloride Injection) as a positive control.
Detailed description
This is a multicenter, randomized, double-blind, positive drug parallel controlled clinical trial, planned to include 358 subjects, including 179 in the experimental group and 179 in the control group. The entire study was divided into a screening period, surgery day, and follow-up observation period. The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h. The experiment used vital signs, physical examination, laboratory examination, 12-lead electrocardiogram examination, and adverse events/serious adverse events for safety evaluation.
Interventions
DRUGBT-KTM-I
The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.
DRUGKetanest®S
The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.
Sponsors
Chengdu Brilliant Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Age range from 18 to 60 years old (including threshold), regardless of gender; 2. Patients undergoing elective general anesthesia laparoscopic surgery (only tracheal intubation mechanical ventilation), 1 hour ≤ expected anesthesia time ≤ 2.5 hours; 3. The American Society of Anesthesiologists (ASA) score of Class I or II; 4. 18kg/m2\<BMI\<30kg/m2; 5. The subjects understand the purpose and procedure of this experiment, voluntarily participate in this experiment, and sign a written informed consent form.
Exclusion criteria
1. Patients with contraindications to general anesthesia, or those who have had previous anesthesia accidents; 2. Known intolerance or allergy to ketamine hydrochloride, esketamine hydrochloride, propofol, rocuronium bromide, opioids, neostigmine, atropine, belladonnae alkaloids; 3. Long-term (continuous or intermittent) use of benzodiazepines sleeping pills, opioid analgesics, or use of narcotic analgesics within 24 hours before randomization or use of narcotic drugs within 7 days; 4. Have a history of increased intraocular pressure (such as glaucoma) or puncture eye injury; 5. Patients with a history of asthma; 6. Patients with mental system diseases (schizophrenia, mania, insanity, etc.) or cognitive disorders; 7. Patients with a history of craniocerebral injury, possible presence of intracranial hypertension, cerebral aneurysm, cerebrovascular accident, and central nervous system disease; 8. Have a serious history of cardiovascular diseases (such as myocardial ischemia, heart failure and severe arrhythmia); Angina pectoris (unstable angina) caused by insufficient blood supply to the coronary arteries of the heart, or myocardial infarction occurring within the first 6 months before screening; 9. Hypertensive patients with systolic blood pressure still ≥ 140mmHg and/or diastolic blood pressure still ≥ 90mmHg after treatment with antihypertensive drugs; 10. Diabetic patients whose blood glucose was not satisfactorily controlled (fasting blood glucose ≥11.1mmol/L during the screening period); 11. Severe lipid metabolism abnormalities (such as triglycerides\>5mmol/L, diabetic hyperlipidemia, familial hypercholesterolemia, lipoid nephropathy, acute pancreatitis with hyperlipidemia, etc.); 12. Have a history of hyperthyroidism; 13. Have a history of drug use within 2 years before screening; 14. Individuals with a history of alcohol abuse within 2 years before screening. alcoholism is defined as drinking more than 14 units of alcohol per week (1 unit =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or acute alcoholism or alcohol dependence; 15. Participants in any clinical trial (defined as receiving the experimental drug or placebo) within 3 months prior to screening; 16. Patients with respiratory management difficulties as determined by the investigators (modified Markov score level Ⅳ); 17. Abnormal coagulation function (PT or PT-INR ≥ 1.5×ULN, APTT ≥ 1.5×ULN), or with bleeding tendency (such as active digestive ulcer) or undergoing thrombolytic or anticoagulant treatment; 18. Anemia or thrombocytopenia (PLT≤80×109/L, HGB≤90g/L); 19. Abnormal liver function \[ALT and (or) AST≥1.5×ULN, TBIL≥1.5×ULN\]; 20. Abnormal renal function (BUN≥1.5×ULN; Cr≥1.2×ULN) 21. Pregnant or lactating women; Women or men with fertility are unwilling to use contraception between the screening period and the end of the trial; 22. Subjects who are deemed by the investigators to have any other unfavorable factors for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The awakening time from anesthesia | The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions in the mental system | Within 60 minutes after the subject wakes up |
Countries
China
Outcome results
None listed