The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd.
• Treatments: Esketamine; Ketamine

Criteria

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/m25. 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.