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Induction and Maintenance of General AnesthesiaPhase 3NCT04511728

A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia

A Phase 3 study testing HSK3486 and Propofol in people with Induction and Maintenance of General Anesthesia, run by 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, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
HSK3486 and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteChina
Study dates
24 Nov 2020to 25 Jan 2021
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In-patients undergoing non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries with expected operation time ≥ 1 h and requiring tracheal intubation under general anesthesia (patients whose surgery type may affect the collection of BIS parameter should not be included);
  • Male or female, age ≥ 18 and ≤ 65 years old;
  • American Society of Anesthesiologists (ASA) class I-III;
  • Body mass index (BMI) ≥ 18 and ≤ 30 kg/m^2;
  • Vital signs in the screening period meeting the following criteria:
  • Respiration rate ≥ 10 and ≤ 24 breaths/min;
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  • SpO2 while breathing ≥ 95%;
  • Systolic blood pressure ≥ 90 mmHg and ≤ 160 mmHg;
  • Diastolic blood pressure ≥ 60 mmHg and ≤ 100 mmHg;
  • Heart rate ≥ 55 and ≤ 100 bpm. (Note: The heart rate is judged by the results of ECG monitoring after signing the ICF, and the heart rate results of 12-lead ECG examination are not used as the basis for judgment.)
  • Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with study protocol.

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;
  • The following disease history or evidence that increases the risk of sedation/anesthesia is collected before/during screening:
  • History of cardiovascular diseases: uncontrolled hypertension or SBP > 160 mmHg and/or DBP > 100 mmHg after treatment with antihypertensive drugs, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction, tachycardia/bradycardia requiring medication, or third-degree atrioventricular block within 6 months before screening, or QTcF interval of ≥ 450 ms (corrected using Fridricia's formula) during the screening period;
  • History of respiratory diseases: respiratory insufficiency, history of obstructive pulmonary disorders, history of bronchospasm requiring treatment within 3 months before screening, and acute respiratory infection with one of the symptoms such as obvious fever, wheezing or productive cough within 1 week before the baseline period;
  • History of neurological and psychiatric disorders: craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysms, cerebrovascular accidents; or schizophrenia, mania, long-term use of psychotropic drugs, history of cognitive impairment, etc.;
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  • History of gastrointestinal tract diseases: gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration judged by the investigator;
  • Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥ 11.1 mmol/L, and/or random blood glucose ≥ 13.6 mmol/L);
  • Patient 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 of the following respiratory management risks before/during screening:
  • Asthma history and stridor;
  • Sleep apnea syndrome;
  • History or family history of malignant hyperthermia;
  • History of intubation failure;
  • Judged by the investigator to have difficult airway or judged as difficult tracheal intubation (modified Mallampati score III or IV).
  • In receipt of any of the following drugs or therapies prior to screening:
  • Participated in other clinical drug trials within 1 month prior to screening;
  • Used drugs that may affect QT intervals within 2 weeks prior to screening;
  • In receipt of propofol, other general sedatives/anesthetics, and/or opioid analgesics or compounds containing opioid analgesics within 3 days prior to screening.
  • Patient whose laboratory test results measured at screening reach the following criteria and are verified through re-examination:
  • Neutrophil count ≤ 1.5 × 10^9/L;
  • Platelet count < 80 × 10^9/L;
  • Hemoglobin < 90 g/L (no blood transfusion within the last 14 days);
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3.0 × ULN;
  • Total bilirubin > 2 × ULN;
  • Blood creatinine > 1.5 × ULN.
  • Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception method during the trial; subjects who are planning pregnancy within 3 months 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

  • West China Hospital，Sichuan University

    Chengdu

Other trials in China

About this study

Official title: A Multi-center, Randomized, Single-blind, Propofol Injectable Emulsion Parallel-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion in the Induction of General Anesthesia in Patients Undergoing Elective Surgery

This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Being tested
HSK3486, Propofol

What participants receive

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

  • HSK3486Drug

    The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h

  • PropofolDrug

    The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h

Study groups in NCT04511728
Study groupRoleWhat they receive
HSK3486ExperimentalNot described
Receives: Drug: HSK3486
PropofolActive comparatorNot described
Receives: Drug: Propofol

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

Secondary outcomes (6)

  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 top-up doses), and no remedial anesthetic is used.

    Measured: During induction of general anesthesia on day 1

  2. Percentage of time from the beginning of surgical skin incision to the end of surgery

    when bispectral index (BIS) is ≥ 40 and ≤ 60.

    Measured: During maintenance of general anesthesia on day 1

  3. Time to recovery from anesthesia

    3 consecutive MOAA/S = 5. 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

  4. 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

  5. Time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9.

    Measured: A period of time from discontinuation of the study drug to 3 consecutive Aldrete score ≥ 9 on day 1

  6. Number of patients with adverse events

    Safety endpoints

    Measured: Pre-dose to 48 hours post-dose

Timeline

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

  1. First posted13 Aug 2020
  2. Study start24 Nov 2020
  3. Primary completion31 Dec 2020
  4. Study completion25 Jan 2021

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
Single blind
Who is masked
Participant
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511728
Sponsor's protocol ID
HSK3486-306
Status last verified
May 2022
First submitted
11 Aug 2020
Last updated
31 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liang P, Dai M, Wang X, Wang D, Yang M, Lin X, Zou X, Jiang K, Li Y, Wang L, Shangguan W, Ren J, He H. Efficacy and safety of ciprofol vs. propofol for the induction and maintenance of general anaesthesia: A multicentre, single-blind, randomised, parallel-group, phase 3 clinical trial. Eur J Anaesthesiol. 2023 Jun 1;40(6):399-406. doi: 10.1097/EJA.0000000000001799. Epub 2023 Jan 19.

    PubMed 36647565

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HSK3486 and Propofol in people with Induction and Maintenance of General Anesthesia, run by 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 11 inclusion and 31 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 31 May 2022. 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 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?

Success rate of anesthesia maintenance (time frame: During maintenance of general anesthesia on day 1). 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 NCT04511728, which also lists 1 linked publication.

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 31 May 2022.

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