Induction of AnesthesiaPhase 3NCT03808844
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects
A Phase 3 study testing HSK3486 and Propofol in people with Induction of Anesthesia, run by Sichuan Haisco Pharmaceutical Group Co., Ltd at 1 site in China.
Trial summary
This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between propofol and HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to provide reference for marketing registration of HSK3486. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Induction of Anesthesia
- What is being tested?
- HSK3486 and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2019to 3 Sep 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In-patients requiring tracheal intubation under general anesthesia for non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries;
- Male or female, ages between 18-64 (inclusive);
- ASA (American Society of Anesthesiologists) Class I-II (see Appendix 4);
- Body mass index (BMI) ≥18 and ≤30 kg/m2;
- Vital signs: Respiratory rate ≥10 and ≤24 breaths per minute; blood oxygen saturation (SpO2) when inhaling ≥95%; systolic blood pressure (SBP) ≥90 mmHg and ≤160 mmHg; diastolic blood pressure (DBP) ≥60 mmHg and ≤100 mmHg; heart rate ≥55 and ≤100 bpm;
- 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 and HSK3486 injections (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, sevoflurane, atropine, and neostigmine; 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/at baseline, which may increase sedation/anesthesia risk:
- History of cardiovascular diseases: 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 within 6 months before screening, history of tachycardia/bradycardia requiring medication, third-degree atrioventricular block or QTcF interval ≥450 ms (Fridericia's correction formula, see Appendix 2) during screening;
- Respiratory system disorders: Respiratory insufficiency, history of obstructive pulmonary disease, 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 baseline;
- History of cerebrovascular disease: 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;
- 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, abuse defined as average of >2 units of alcohol per day (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol or 150 mL 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 );
- In receipt of any of the following drugs or therapies prior to screening:
- Participated in other drug trials within 1 month prior to screening;
- In receipt of medications that may affect QT interval within 2 weeks prior to screening (see Appendix 5);
- In receipt of medications that induce or inhibit cytochrome P450 isoenzyme CYP2B6 within 2 weeks prior to screening (see Appendix 6);
- In receipt of propofol, other sedatives/anesthetics, and/or opioid analgesics or compounds containing analgesics within 3 days prior to screening.
- Laboratory results meeting any of the following criteria during screening/at baseline, confirmed by re-examination:
- Neutrophil count ≤1.5×109/L;
- Platelet count <80×109/L;
- Hemoglobin <90 g/L (no blood transfusion within the last 14 days);
- ALT and/or AST ≥2.0×upper limit of normal (ULN);
- Total bilirubin ≥2.0×ULN;
- Serum creatinine ≥1.5×ULN.
- 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.
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects
This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between propofol and HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to provide reference for marketing registration of HSK3486.
- Conditions
- Induction of Anesthesia
- Being tested
- HSK3486, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed.
PropofolDrug
Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | 0.4mg/kg/0.2 mg/kg Receives: Drug: HSK3486 |
| Propofol | Active comparator | 2.0mg/kg/1.0mg/kg Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of induction of anesthesia
Measured: During induction of general anesthesia on day 1
Secondary outcomes (6)
Time to successful anesthetic induction
Measured: From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1
Time to loss of eyelash reflex
Measured: From the initial administration of the investigational drug to loss of eyelash reflex on day 1
Use of the investigational drug and alternative drugs
Measured: During induction of general anesthesia on day 1
Use of the alternative drugs
Measured: During induction of general anesthesia on day 1
Changes in bispectral index (BIS)（score：0~100）
Measured: During induction of general anesthesia on day 1
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.
- First posted18 Jan 2019
- Study start22 Mar 2019
- Primary completion14 Aug 2019
- Study completion3 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808844
- Sponsor's protocol ID
- HSK3486-302
- Status last verified
- Dec 2018
- First submitted
- 9 Jan 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects
- ClinicalTrials.gov ID
- NCT03808844
- Acronym / sponsor ID
- HSK3486-302
- Conditions
- Induction of Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Sichuan Haisco Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 3 Sep 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, randomized, double-blind, propofol-controlled phase III clinical trial. The primary objective is to compare the efficacy and safety between propofol and HSK3486 for the induction of general anesthesia in elective surgery subjects, so as to provide reference for marketing registration of HSK3486.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK3486 | Experimental | Drug: HSK34860.4mg/kg/0.2 mg/kg |
| Propofol | Active comparator | Drug: Propofol2.0mg/kg/1.0mg/kg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In-patients requiring tracheal intubation under general anesthesia for non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries;
- Male or female, ages between 18-64 (inclusive);
- ASA (American Society of Anesthesiologists) Class I-II (see Appendix 4);
- Body mass index (BMI) ≥18 and ≤30 kg/m2;
- Vital signs: Respiratory rate ≥10 and ≤24 breaths per minute; blood oxygen saturation (SpO2) when inhaling ≥95%; systolic blood pressure (SBP) ≥90 mmHg and ≤160 mmHg; diastolic blood pressure (DBP) ≥60 mmHg and ≤100 mmHg; heart rate ≥55 and ≤100 bpm;
Key exclusion criteria (31 listed)
- Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
- Known hypersensitivity to excipients and ingredients found in propofol and HSK3486 injections (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, sevoflurane, atropine, and neostigmine; 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/at baseline, which may increase sedation/anesthesia risk:
- Any one of the following respiratory risks before/during screening:
- In receipt of any of the following drugs or therapies prior to screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK3486Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed. | Drug | HSK3486 |
| PropofolInitial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed | Drug | Propofol |
Primary outcome
The success rate of induction of anesthesia
Time frame: During induction of general anesthesia on day 1
6 secondary outcomes
Time to successful anesthetic induction
Time frame: From the initial administration of the investigational drug to the first time when MOAA/S is ≤1 on day 1
Time to loss of eyelash reflex
Time frame: From the initial administration of the investigational drug to loss of eyelash reflex on day 1
Use of the investigational drug and alternative drugs
Time frame: During induction of general anesthesia on day 1
Use of the alternative drugs
Time frame: During induction of general anesthesia on day 1
Changes in bispectral index (BIS)（score：0~100）
Time frame: During induction of general anesthesia on day 1
Number of patients with adverse events
Time frame: Pre-dose to 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK3486 and Propofol in people with Induction of 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 6 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 13 Sep 2019. 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?
The success rate of induction of anesthesia (time frame: During induction 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?
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 13 Sep 2019.