The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

Chengdu Brilliant Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Laparoscopy; Anesthesia, Intravenous

Treatments: Drug: Ketanest®S; Drug: BT-KTM-I

Study type: Interventional

Funder types: Industry

Identifiers

NCT06092684

BT-KTM-I-III-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 358 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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358 participants in 2 patient groups

BT-KTM-I

Experimental group

Description:

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.

Treatment:

Drug: BT-KTM-I

Ketanest®S

Active Comparator group

Description:

Patients received 0.5mg/kg Ketanest®S during anesthesia induction period. Patients received 0.5mg/kg/h Ketanest®S during anesthesia maintenance period.

Treatment:

Drug: Ketanest®S