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Induction and Maintenance of General AnesthesiaPhase 2NCT04048811

A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients

A Phase 2 study testing HSK3486, Propofol and Propofol HSK3486 in people with Induction and Maintenance of General Anesthesia, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site 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

This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40 subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control group (10 cases) in a ratio of 3:1. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
HSK3486, Propofol and Propofol HSK3486
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
9 Dec 2019to 22 Jun 2020
Phase
Phase 2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inpatients requiring tracheal intubation under general anesthesia and a non-emergent, non-cardiothoracic, non-extracerebral, and non-nasal endoscopic elective surgery for an estimated duration of about 1-6 h, with an bleeding volume of ≤ 1000 mL
  • Aged ≥ 18 and ≤ 65 years old, regardless of gender;
  • American Society of Anesthesiologists (ASA) Class I-III;
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
  • The vital signs during the screening period meet the following criteria:
  • Respiratory rate ≥ 10 and ≤ 24 breaths/min;
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  • Blood oxygen saturation (SpO2) ≥ 95% when inhaling;
  • Systolic blood pressure (SBP) ≥ 90 mmHg and ≤ 160 mmHg;
  • Diastolic blood pressure (DBP) ≥ 60 mmHg and ≤ 100 mmHg;
  • Heart rate ≥ 55 beats/min and ≤ 100 beats/min;
  • The laboratory parameters measured at screening period reach the following criteria:
  • Neutrophil count ≥ 1.5 × 109/L;
  • Platelet count ≥ 80 × 109/L;
  • Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days);
  • ALT and AST ≤ 3.0 × upper limit of normal (ULN);
  • Total bilirubin ≤ 1.5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN.
  • Subjects who understand the procedures and methods of this study, and are willing to complete the trial in strict accordance with clinical trial protocol and sign the informed consent.

Who cannot join

  • Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
  • Known hypersensitivity to excipients and ingredients found in propofol injection and HSK3486 injectable emulsion (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, and sugammadex sodium; cross-reactivity to halogenated anesthetics, jaundice or unexplained fever from previous use of halogenated anesthetics; contraindications to propofol;
  • Medical history or evidence of any of the following prior to screening, which may increase sedation/anesthesia risk:
  • History of cardiovascular disease: Uncontrolled hypertension or SBP > 160 mmHg and/or DBP > 100 mmHg despite antihypertensive treatment, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction occurring in almost 6 months prior to screening, and history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF ≥ 450 ms (male) or ≥ 470 ms (female) (corrected using Fridericia's formula) during screening period.
  • Respiratory system disorders: Respiratory insufficiency, history of bronchospasm requiring treatment within 3 months prior to screening, acute respiratory tract infection with obvious symptoms such as fever, wheezing, or productive cough within 1 week prior to administration of the study drug;
  • History of craniocerebral disease: Patient with a history of craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysm, or cerebrovascular accident; history of schizophrenia, mania, chronic use of antipsychotics, or cognitive impairment.
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  • Gastrointestinal disease history: Gastrointestinal retention, active hemorrhage, or circumstances that may lead to reflux and aspiration.
  • Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥ 11.1 mmol/L, and/or random blood glucose ≥ 13.6 mmol/L).
  • Patients with a history of uncontrolled and clinically significant liver, kidney, blood system, nervous system or metabolic system diseases judged by the investigator to be unsuitable for this trial.
  • History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking > 2 units of alcohol (1 unit = 360 mL of beer or 45 mL of liquor with 40% alcohol or 150 mL of wine).
  • History of drug abuse within 3 months prior to screening.
  • Serious infection, trauma, or major surgery within 4 weeks prior to screening.
  • Any one of the following respiratory risks before/during screening:
  • Asthma history, and stridor.
  • Sleep apnea syndrome.
  • History of malignant hyperthermia or family history.
  • History of failed tracheal intubation.
  • Judged by the investigator to have difficult airway or judged as difficult tracheal intubation (modified Mallampati score III or IV);
  • Received any of the following drugs or therapies prior to screening:
  • Participated in other drug trials within 1 month prior to screening.
  • Using the drugs that may affect QT interval within 2 weeks prior to screening.
  • Using propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 3 days prior to screening.
  • Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
  • Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing

Other trials in China

About this study

Official title: A Multi-Center, Randomized, Open-Label, Positive-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction and Maintenance of General Anesthesia in Elective Surgery Patients.

This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40 subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly enter into propofol induction + HSK3486 maintenance group for study.

Being tested
HSK3486, Propofol, Propofol HSK3486

What participants receive

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

  • HSK3486Drug

    The induction dose is 0.4mg/mg. The initial maintenance dose of the first 6 subjects is 1 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 6 subjects, so as to explore the optimal initial maintenance dose. The range of the initial maintenance dose is 1 (± 0.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 0.5 mg/kg/h, and the maximum should not be more than 1.5 mg/kg/h.

  • PropofolDrug

    The induction dose is 2.0mg/mg. The initial maintenance dose of the first 2 subject is 5 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 2 subjects, so as to explore the optimal initial maintenance dose. The adjustment range of the initial maintenance dose is 5 (± 2.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 2.5 mg/kg/h, and the maximum should not be more than 7.5 mg/kg/h.

  • Propofol HSK3486Drug

    The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.

Study groups in NCT04048811
Study groupRoleWhat they receive
HSK3486ExperimentalHSK3486 induction + maintenance group
Receives: Drug: HSK3486
PropofolActive comparatorPropofol induction + maintenance group
Receives: Drug: Propofol
Propofol HSK3486OtherPropofol induction + HSK3486 maintenance group
Receives: Drug: Propofol HSK3486

What is being measured

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

  1. Success rate of anesthesia maintenance

    During the maintenance of anesthesia, the subject is not recovered and no remedial anesthetic is used

    Measured: During maintenance of general anesthesia on day 1

  2. Number of patients with adverse events

    Safety endpoints

    Measured: Pre-dose to 48 hours post-dose

Secondary outcomes (9)

  1. Success rate of anesthesia induction

    During the induction of anesthesia, the subject achieves successful induction (i.e., MOAA/S ≤ 1) after administration of the study drug (up to 2 additional doses), and no remedial anesthetic is used.

    Measured: During induction of general anesthesia on day 1

  2. Success rate of anesthesia

    The proportion of subjects who are successfully induced and successfully maintain anesthesia in all subjects.

    Measured: During induction and maintenance of general anesthesia on day 1

  3. Changes in Bispectral index

    Bispectral index (BIS) is used to adjust the administration dose during anesthesia maintenance to maintain BIS at 40-60

    Measured: During maintenance of general anesthesia on day 1

  4. Time to successful induction of anesthesia

    A period of time from the start of the first administration of the study drug to the first time when MOAA/S is ≤ 1.

    Measured: Time to successful induction of anesthesia on day 1

  5. Time to recovery from anesthesia

    6.Record the time when MOAA/S = 5 is reached for the first time.

    Measured: A period of time from discontinuation of the study drug to recovery after the end of surgery on day 1.

  6. Time to respiratory recovery

    Respiratory rate ≥ 8 breaths/min and the tidal volume ≥ 5 mL/kg.

    Measured: A period of time from discontinuation of the study drug to respiratory recovery after the end of surgery on day 1.

  7. Time to extubation

    Measured: A period of time from discontinuation of the study drug to extubation after the end of surgery on day 1.

  8. Time to leaving the operating room

    Measured: A period of time from discontinuation of the study drug to leaving the operating room after the end of surgery on day 1.

  9. Time to leaving postanesthesia care unit(PACU)

    Measured: A period of time from discontinuation of the study drug to leaving PACU after the end of surgery on day 1.

Timeline

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

  1. First posted7 Aug 2019
  2. Study start9 Dec 2019
  3. Primary completion23 May 2020
  4. Study completion22 Jun 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04048811
Sponsor's protocol ID
HSK3486-204
Status last verified
Dec 2020
First submitted
31 Jul 2019
Last updated
17 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK3486, Propofol and Propofol HSK3486 in people with Induction and Maintenance of General Anesthesia, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site 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 18 inclusion and 24 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Success rate of anesthesia maintenance (time frame: During maintenance of general anesthesia on day 1). The study lists 2 primary outcomes in all. 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 NCT04048811.

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 17 Dec 2020.

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