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SedationPhase 2NCT04147416

A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation

A Phase 2 study testing HSK3486 0.1-0.2 /0.3 mg / kg group and Propofol 0.5-1.0/1.5 mg/kg group in people with Sedation, 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, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation 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 80 years
Conditions the study is for
Sedation
What is being tested?
HSK3486 0.1-0.2 /0.3 mg / kg group and Propofol 0.5-1.0/1.5 mg/kg group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
22 Nov 2019to 3 Jul 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who need tracheal intubation for mechanical ventilation and need 6-24 h of sedation after randomization, as anticipated;
  • The target RASS score is between +1 and -2;
  • 18 ≤ age < 80 years old; with no restriction on gender;
  • 18 kg/m2 ≤ BMI ≤ 30 kg/m2;
  • The patients or their family members well understand the purpose and significance of the trial, voluntarily participate in this clinical trial, and sign the informed consent form.

Who cannot join

  • Patients known to be allergic to eggs, soy products, opioids and their antidotes, and propofol; patients having contraindications to propofol, opioids and their antidotes;
  • Patients having the following medical history or evidence at screening, which may increase sedation/anesthesia risk:
  • Cardiovascular system: Class III and IV heart failure by New York Heart Association (NYHA), Adams-Stokes syndrome; acute coronary syndrome (ACS) within 6 months prior to screening; bradycardia requiring medications and/or heart rate ≤ 50 beats/min; serious arrhythmia history such as Degree II-III atrioventricular block (excluding patients with pacemakers); acute and chronic myocarditis; systolic pressure ≤ 90 mmHg even when large dose of vasoactive drug (such as norepinephrine ≥ 0.6 μg/kg/min) is used;
  • Patients with mental disorders (such as schizophrenia, depression, etc.) and cognitive impairment; past abuse history of psychotropics and anesthetics, and long-term use of psychotropics;
  • Patients with moderate to severe hepatic and renal dysfunctions (liver function: Child-Pugh Grade B and C, scale in Annex 9; renal function: glomerular filtration rate eGFR ≤ 60 mL/(min•1.73 m2) [eGFR is calculated with the Modification of Diet in Renal Disease (MDRD) formula: eGFR = 186 × serum creatinine (SCr)-1.154 × age-0.203 × 0.742 (female)]; patients under dialysis;
  • Epileptic seizures, convulsions; craniocerebral injury, intracranial hypertension, cerebral aneurysms; Glasgow Coma Score (GCS) ≤ 12 (scale in Annex 6); SOFA > 9 (scale in Annex 7);
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  • Expected survival ≤ 72 h;
  • Laboratory measures at screening period meet the following criteria:
  • Neutrophil count ≤ 1.0 × 10^9/L;
  • Platelet count ≤ 50 × 10^9/L;
  • Hemoglobin ≤ 70 g/L;
  • Pregnant or lactating females; fertile females or males reluctant to receive contraception through the study; any subject planning for pregnancy within 1 month after the study (including male subject);
  • Participated in other drug clinical trials within 1 month prior to screening; Other reasons rendering a subject unsuitable for participation in this study as per the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Sun Yat-sen University

    Guanzhou, Guangdong

Other trials in China

About this study

Official title: A Multi-center, Open-label, Randomized, Propofol-controlled Study Evaluating the Efficacy and Safety of Intravenous Administration of HSK3486 Injectable Emulsion for Sedation in Intensive Care (ICU) Patients Undergoing Mechanical Ventilation

This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.

Conditions
Sedation
Being tested
HSK3486 0.1-0.2 /0.3 mg / kg group, Propofol 0.5-1.0/1.5 mg/kg group

What participants receive

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

  • HSK3486 0.1-0.2 /0.3 mg / kg groupDrug

    Administered with HSK3486 at a loading dose of 0.1-0.2 mg/kg via intravenous pump. Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.

  • Propofol 0.5-1.0/1.5 mg/kg groupDrug

    Administered with Propofol at a loading dose of 0.5-1.0mg/kg via intravenous pump. Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.

Study groups in NCT04147416
Study groupRoleWhat they receive
HSK3486ExperimentalHSK3486 for Sedation
Receives: Drug: HSK3486 0.1-0.2 /0.3 mg / kg group
PropofolActive comparatorPropofol for Sedation
Receives: Drug: Propofol 0.5-1.0/1.5 mg/kg group

What is being measured

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

  1. Mean time to sedation

    Defined as the mean time during which the hourly RASS is in the range of +1- -2 during the study treatment

    Measured: at day 1

Secondary outcomes (6)

  1. Study drug use

    Including the loading dose, maintenance dose, additional dose of HSK3486 and propofol, average unit weight dose per hour of HSK3486 or propofol, total and hourly average numbers of dose adjustments

    Measured: at day 1

  2. Minimum maintenance dose

    Defined as the minimum dose to maintain the target sedation level (RASS between +1 and -2) of the subject for ≥ 2 h and ≥ 4 h during the administration period

    Measured: at day 1

  3. Unit weight dose of remedial drug

    Defined as the average hourly unit weight dose of sedatives other than propofol administered for maintaining a target sedation level (RASS between +1 and -2) during the administration period

    Measured: at day 1

  4. Unit weight dose of remifentanil

    Defined as the average hourly unit weight dose of remifentanil for analgesia during the administration period

    Measured: at day 1

  5. Extubation time

    Defined as the time from ICU admission to extubation (applicable for subjects who have been intubated before admitted to ICU) or the time from intubation to extubation (applicable for subjects who are intubated after admitted to ICU); for withdrawals, the time of extubation is calculated according to the time of discontinuation; if the extubation does not occur within 24 h of administration, the time of extubation is recorded as 24 h

    Measured: at day 1

  6. Recovery time

    Defined as the time to recover from sedation status to awaken status (RASS ≥ 0) after drug discontinuation, accurate to the minute; if RASS is ≥ 0 at discontinuation, the recovery time is recorded as 0

    Measured: at 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 posted1 Nov 2019
  2. Study start22 Nov 2019
  3. Primary completion31 May 2020
  4. Study completion3 Jul 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
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147416
Sponsor's protocol ID
HSK3486-205
Status last verified
May 2022
First submitted
30 Oct 2019
Last updated
27 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu Y, Zuo L, Li X, Nie Y, Chen C, Liu N, Chen M, Wu J, Guan X. Early sedation using ciprofol for intensive care unit patients requiring mechanical ventilation: a pooled post-hoc analysis of data from phase 2 and phase 3 trials. Ann Intensive Care. 2024 Oct 26;14(1):164. doi: 10.1186/s13613-024-01390-3.

    PubMed 39455495

  • Liu Y, Yu X, Zhu D, Zeng J, Lin Q, Zang B, Chen C, Liu N, Liu X, Gao W, Guan X. Safety and efficacy of ciprofol vs. propofol for sedation in intensive care unit patients with mechanical ventilation: a multi-center, open label, randomized, phase 2 trial. Chin Med J (Engl). 2022 May 5;135(9):1043-1051. doi: 10.1097/CM9.0000000000001912.

    PubMed 34924506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK3486 0.1-0.2 /0.3 mg / kg group and Propofol 0.5-1.0/1.5 mg/kg group in people with Sedation, 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 5 inclusion and 13 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 27 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 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?

Mean time to sedation (time frame: at 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 NCT04147416, which also lists 2 linked publications.

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 27 May 2022.

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