The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

Laparoscopy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092684
• Other study ID #: BT-KTM-I-III-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Chengdu Brilliant Pharmaceutical Co., Ltd.
• Contact: Wen Ouyang, MD
• Phone: 0731-88618151
• Email: Ouyangwen133[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 358
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 ?);

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.

Related Conditions & MeSH terms

• Anesthesia, Intravenous
• Laparoscopy

Intervention

Drug:
• 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.
• Ketanest®S
The dosage for anesthesia induction period was 0.5mg/kg, and the dosage for anesthesia maintenance period was 0.5mg/kg/h.

Locations

Country	Name	City	State
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	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 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	The Second Hospital University of South China	Hengyang	Hunan
China	The Second People's hospital of Neijiang	Neijiang	Sichuan
China	The Second People's Hospital of Yibin	Yibin	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Brilliant Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The awakening time from anesthesia		The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)
Secondary	Incidence of adverse reactions in the mental system		Within 60 minutes after the subject wakes up