Status:
COMPLETED
The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery
Lead Sponsor:
Chengdu Brilliant Pharmaceutical Co., Ltd.
Conditions:
Laparoscopy
Anesthesia, Intravenous
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2024
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT06092684
Start Date
September 20 2023
End Date
March 19 2024
Last Update
July 29 2024
Active Locations (12)
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1
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
2
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
3
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
4
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China