Laparoscopy Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of BT-KTM-I Versus Ketanest® S for General Anesthesia in Elective Laparoscopic Surgery
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.
Status | Not yet recruiting |
Enrollment | 358 |
Est. completion date | April 2024 |
Est. primary completion date | January 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 ?); 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. |
Country | Name | City | State |
---|---|---|---|
China | Hunan Provincial Maternal and Child Health Care Hospital | Changsha | Hunan |
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
China | Pidu District People's Hospital, Chengdu | Chengdu | Sichuan |
China | Sichuan Provincial People's Hospital | Chengdu | Sichuan |
China | West China Second University Hospital, Sichuan University | Chengdu | Sichuan |
China | The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong |
China | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
China | Guizhou Provincial People's Hospital | Guiyang | Guizhou |
China | The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou |
China | The Second Hospital University of South China | Hengyang | Hunan |
China | The Second People's hospital of Neijiang | Neijiang | Sichuan |
China | The Second People's Hospital of Yibin | Yibin | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Chengdu Brilliant Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Incidence of adverse reactions in the mental system | Within 60 minutes after the subject wakes up |
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