CompletedPhase 3ketamine

The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

Sponsored by Chengdu Brilliant Pharmaceutical Co., Ltd.

NCT ID
NCT06092684
Target Enrollment
358 participants
Start Date
2023-09-20
Est. Completion
2024-03-19

About This Study

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.

Conditions Studied

LaparoscopyAnesthesia, Intravenous

Interventions

  • BT-KTM-I
  • Ketanest®S

Eligibility

Age:18 Years - 60 Years
Healthy Volunteers:No
View full 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.

Study Locations (12)

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
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Hospital University of South China
Hengyang, 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

+2 more locations

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery | Huxley