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LaparoscopyPhase 3NCT06092684

The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery

A Phase 3 study testing BT-KTM-I and Ketanest®S in people with Laparoscopy and Anesthesia, Intravenous, run by Chengdu Brilliant Pharmaceutical Co., Ltd. at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Laparoscopy, Anesthesia, Intravenous
What is being tested?
BT-KTM-I and Ketanest®S
Could I receive a placebo?
No, everyone receives an active treatment
How many people
358 participants
Where
12 sitesChina
Study dates
20 Sep 2023to 19 Mar 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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;
  • 18kg/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.

Who cannot join

  • 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;
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  • 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;
  • Patients with respiratory management difficulties as determined by the investigators (modified Markov score level Ⅳ);
  • 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;
  • Anemia or thrombocytopenia (PLT≤80×109/L, HGB≤90g/L);
  • Abnormal liver function [ALT and (or) AST≥1.5×ULN, TBIL≥1.5×ULN];
  • Abnormal renal function (BUN≥1.5×ULN; Cr≥1.2×ULN)
  • Pregnant or lactating women; Women or men with fertility are unwilling to use contraception between the screening period and the end of the trial;
  • Subjects who are deemed by the investigators to have any other unfavorable factors for participating in this clinical trial.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Hunan Provincial Maternal and Child Health Care Hospital

    Changsha, Hunan

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Pidu District People's Hospital, Chengdu

    Chengdu, Sichuan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The Second Hospital University of South China

    Hengyang, Hunan

  • The Second People's hospital of Neijiang

    Neijiang, Sichuan

  • The Second People's Hospital of Yibin

    Yibin, Sichuan

Other trials in China

About this study

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

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.

Read the 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.

Being tested
BT-KTM-I, Ketanest®S

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BT-KTM-IDrug

    Also called Esketamine

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

  • Ketanest®SDrug

    Also called Esketamine

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

Study groups in NCT06092684
Study groupRoleWhat they receive
BT-KTM-IExperimentalPatients received 0.5mg/kg BT-KTM-I during anesthesia induction period. Patients received 0.5mg/kg/h BT-KTM-I during anesthesia maintenance period.
Receives: Drug: BT-KTM-I
Ketanest®SActive comparatorPatients received 0.5mg/kg Ketanest®S during anesthesia induction period. Patients received 0.5mg/kg/h Ketanest®S during anesthesia maintenance period.
Receives: Drug: Ketanest®S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The awakening time from anesthesia

    Measured: 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)

  1. Incidence of adverse reactions in the mental system

    Measured: Within 60 minutes after the subject wakes up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start20 Sep 2023
  3. Primary completion19 Mar 2024
  4. Study completion19 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
358 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06092684
Sponsor's protocol ID
BT-KTM-I-III-01
Status last verified
Jul 2024
First submitted
21 Sep 2023
Last updated
29 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BT-KTM-I and Ketanest®S in people with Laparoscopy and Anesthesia, Intravenous, run by Chengdu Brilliant Pharmaceutical Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06092684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.

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