The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Laparoscopy, Anesthesia, Intravenous

Intervention / Treatment
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* Drug: BT-KTM-I
* Drug: Ketanest®S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age range from 18 to 60 years old (including threshold), regardless of gender; Patients undergoing elective general anesthesia laparoscopic surgery (only tracheal intubation mechanical ventilation), 1 hour ≤ expected anesthesia time ≤ 2.5 hours; The American Society of Anesthesiologists (ASA) score of Class I or II; 18kg/m2<BMI<30kg/m2; The subjects understand the purpose and procedure of this experiment, voluntarily participate in this experiment, and sign a written informed consent form. Exclusion Criteria: Patients with contraindications to general anesthesia, or those who have had previous anesthesia accidents; Known intolerance or allergy to ketamine hydrochloride, esketamine hydrochloride, propofol, rocuronium bromide, opioids, neostigmine, atropine, belladonnae alkaloids; 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; Have a history of increased intraocular pressure (such as glaucoma) or puncture eye injury; Patients with a history of asthma; Patients with mental system diseases (schizophrenia, mania, insanity, etc.) or cognitive disorders; Patients with a history of craniocerebral injury, possible presence of intracranial hypertension, cerebral aneurysm, cerebrovascular accident, and central nervous system disease; 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; Hypertensive patients with systolic blood pressure still ≥ 140mmHg and/or diastolic blood pressure still ≥ 90mmHg after treatment with antihypertensive drugs; Diabetic patients whose blood glucose was not satisfactorily controlled (fasting blood glucose ≥11.1mmol/L during the screening period); Severe lipid metabolism abnormalities (such as triglycerides>5mmol/L, diabetic hyperlipidemia, familial hypercholesterolemia, lipoid nephropathy, acute pancreatitis with hyperlipidemia, etc.); Have a history of hyperthyroidism; Have a history of drug use within 2 years before screening; 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; Participants in any clinical trial (defined as receiving the experimental drug or placebo) within 3 months prior to screening; Patients with respiratory management difficulties as determined by the investigators (modified Markov score level Ⅳ); 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; Anemia or thrombocytopenia (PLT≤80×109/L, HGB≤90g/L); Abnormal liver function [ALT and (or) AST≥1.5×ULN, TBIL≥1.5×ULN]; Abnormal renal function (BUN≥1.5×ULN; Cr≥1.2×ULN) Pregnant or lactating women; Women or men with fertility are unwilling to use contraception between the screening period and the end of the trial; Subjects who are deemed by the investigators to have any other unfavorable factors for participating in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BT-KTM-I<br>Patients received 0.5mg/kg BT-KTM-I during anesthesia induction period. Patients received 0.5mg/kg/h BT-KTM-I during anesthesia maintenance period. | Drug: BT-KTM-I<br>* The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.<br>* Other names: Esketamine;|
| Active Comparator: Ketanest®S<br>Patients received 0.5mg/kg Ketanest®S during anesthesia induction period. Patients received 0.5mg/kg/h Ketanest®S during anesthesia maintenance period. | Drug: Ketanest®S<br>* The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.<br>* Other names: Esketamine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse reactions in the mental system |  | Within 60 minutes after the subject wakes up |