The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

NCT06092684 | Completed Phase 3

• 1 other identifier: BT-KTM-I-III-01
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 12

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.

Conditions

Laparoscopy; Anesthesia, Intravenous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of adverse reactions in the mental system

  Within 60 minutes after the subject wakes up

Study Arms (2)

BT-KTM-I

EXPERIMENTAL

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.

Drug: BT-KTM-I

Ketanest®S

ACTIVE COMPARATOR

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

Drug: Ketanest®S

Interventions

BT-KTM-I DRUG

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

Also known as: Esketamine

BT-KTM-I

Ketanest®S DRUG

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

Also known as: Esketamine

Ketanest®S

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• kg/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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chengdu Brilliant Pharmaceutical Co., Ltd.: lead

Study Sites (12)

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Second Hospital University of South China

Hengyang, Hunan, China

Location

Pidu District People's Hospital, Chengdu

Chengdu, Sichuan, China

Location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Location

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Location

The Second People's hospital of Neijiang

Neijiang, Sichuan, China

Location

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Location

MeSH Terms

Interventions

Esketamine

Study Officials

• Wen Ouyang, MD

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 23, 2023
• Study Start: September 20, 2023
• Primary Completion: March 19, 2024
• Study Completion: March 19, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

CN (12)