The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

July 26, 2024 updated by: Chengdu Brilliant Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Jinan University
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provincial People's Hospital
      • Guiyang, Guizhou, China
        • The Affiliated Hospital of Guizhou Medical University
    • Hunan
      • Changsha, Hunan, China
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China
        • Hunan Provincial Maternal and Child Health Care Hospital
      • Hengyang, Hunan, China
        • The Second Hospital University of South China
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Provincial People's Hospital
      • Chengdu, Sichuan, China
        • West China Second University Hospital, Sichuan University
      • Chengdu, Sichuan, China
        • Pidu District People's Hospital, Chengdu
      • Neijiang, Sichuan, China
        • The Second People's Hospital of Neijiang
      • Yibin, Sichuan, China
        • The Second People's Hospital of Yibin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Other Names:
  • Esketamine
Active Comparator: 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.
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.
Other Names:
  • Esketamine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The awakening time from anesthesia
Time Frame: The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)
The time from discontinuing the use of anesthetics (propofol) to subjects waking up immediately after surgery (following instructions to open their eyes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of adverse reactions in the mental system
Time Frame: Within 60 minutes after the subject wakes up
Within 60 minutes after the subject wakes up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu Brilliant Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wen Ouyang, MD, The Third XIANGYA Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BT-KTM-I-III-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings