The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

NCT ID: NCT06092684

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-20
• Study Completion Date: 2024-03-19

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.

Conditions

Laparoscopy; Anesthesia, Intravenous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BT-KTM-I

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.

Group Type: EXPERIMENTAL

BT-KTM-I

Intervention Type: DRUG

The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Ketanest®S

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

Group Type: ACTIVE_COMPARATOR

Ketanest®S

Intervention Type: DRUG

The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Interventions

BT-KTM-I

The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Intervention Type: DRUG

Ketanest®S

The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Intervention Type: DRUG

Other Intervention Names

Esketamine; Esketamine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Brilliant Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen Ouyang, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

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

The Second People's hospital of Neijiang

Neijiang, Sichuan, China

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Countries

China

Other Identifiers

BT-KTM-I-III-01

Identifier Type: -

Identifier Source: org_study_id