Clinical trial NCT06092684: The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopy
Anesthesia, Intravenous
Lead sponsor: Chengdu Brilliant Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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/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.

Primary outcomes:
measure: The awakening time from anesthesia
timeFrame: The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)
Secondary outcomes:
measure: Incidence of adverse reactions in the mental system
timeFrame: Within 60 minutes after the subject wakes up
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Hengyang
country: China
facility: The Second Hospital University of South China
state: Hunan
city: Chengdu
country: China
facility: Pidu District People's Hospital, Chengdu
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
city: Neijiang
country: China
facility: The Second People's hospital of Neijiang
state: Sichuan
city: Yibin
country: China
facility: The Second People's Hospital of Yibin
state: Sichuan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Wen Ouyang, MD
role: PRINCIPAL_INVESTIGATOR
References: