AzTrials
AzTrials

Induction of General AnaesthesiaPhase 2NCT03698617

A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486

A Phase 2 study testing HSK3486 and Propofol in people with Induction of General Anaesthesia, 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
Search all trials

Trial summary

This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Induction of General Anaesthesia
What is being tested?
HSK3486 and Propofol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
6 Dec 2016to 18 Jul 2018
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 required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
  • Males or females, aged ≥ 18 and ≤ 65 years old;
  • Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
  • ASA grade I~II;
  • Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.

Who cannot join

  • Patients were contraindicated in general anesthesia.;
  • Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
  • Patients in receipt of any investigational drug within 30 days before screening.
  • Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
  • Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
  • The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
Show all 10Show fewer
  • Abnormal laboratory results consisting of any of the following: :
  • 1) AST and ALT≥ 2×ULN； 2）TBIL≥ 1.5×ULN； 3）Hb≤ 90g/L; 4）ANC≤1.5×109/L; 5) PLT≤80×109/L； 6） serum creatinine≥ 1.5×ULN.
  • 8. Patients with a history of drug or ethanol abuse with the past 3 months. 9. Pregnant women or female patients with a positive serum or urine human chorionic gonadotropin pregnancy test at screening or baseline or lactating female patients. . 10. 10. Patients with a positive Allen 's test who collected arterial blood for PK study.
  • 11. Patients with respiratory management difficulties. 12. Patients with an inability to communicate well with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).

Trial locations and contacts

1 site in 1 country.

China1 site

  • The 2nd Affiliated Hospital of WMU

    Wenzhou, Zhejiang, 325027

Other trials in China

About this study

Official title: A Phase IIa, Open-label, Propofol-controlled ,Dose-escalation, Multi-center Study to Evaluate the Tolerance, Efficacy and Safety of HSK3486 for Induction of General Anesthesia in Elective Surgery Patients.

This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.

Being tested
HSK3486, Propofol

What participants receive

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

  • HSK3486Drug

    For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results.

  • PropofolDrug

    For induction of general anesthesia

Study groups in NCT03698617
Study groupRoleWhat they receive
HSK3486ExperimentalDose Escalation Cohort: 0.1 mg/kg, 0.2 mg/kg, 0.3mg/kg 0.4 mg/kg 0.5 mg/kg, 0.6 mg/kg, 0.7mg/kg, 0.8 mg/kg Dose Expansion Cohort: 0.3 mg/kg and 0.5 mg/kg.
Receives: Drug: HSK3486
PropofolActive comparatorDose Escalation Cohorts:2.0mg/kg and 2.5mg/kg; Dose Expansion Cohorts: 2.0mg/kg
Receives: Drug: Propofol

What is being measured

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

  1. The success rate of induction of general anesthesia

    To find the MTD or the RP2D of HSK3486 in the induction of general anesthesia, the success rate of induction of general anesthesia is the primary outcome measurement.

    Measured: during induction of general anesthesia on day 1

Secondary outcomes (8)

  1. Time from start of IMP administration to loss of eyelash reflex

    Measured: during induction of general anesthesia on day 1

  2. Time from start of IMP administration to loss of consciousness

    Measured: during induction of general anesthesia on day 1

  3. Time from start of IMP administration to intubation and the intubation reaction

    Measured: during induction of general anesthesia on day 1

  4. Mini-Mental State Examination (MMSE) total scores(0-30) by time point

    Change from baseline in Mini-Mental State Examination (MMSE) total score

    Measured: Pre-dose to 48 hours post-dose

  5. change from baseline in blood pressure （systolic, diastolic and mean arterial pressure)

    safety endpoits

    Measured: pre-dose to 20 minutes post-dose

  6. change from baseline in heart rate

    safety endpoits

    Measured: pre-dose to 20 minutes post-dose

  7. change from baseline in arterial oxygen saturation

    safety endpoits

    Measured: pre-dose to 20 minutes post-dose

  8. Number of patients with adverse events

    safety endpoits

    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 posted9 Oct 2018
  2. Study start6 Dec 2016
  3. Primary completion29 Jun 2018
  4. Study completion18 Jul 2018

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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698617
Sponsor's protocol ID
HSK3486-202
Status last verified
Sep 2018
First submitted
18 Sep 2018
Last updated
9 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhu Q, Luo Z, Wang X, Wang D, Li J, Wei X, Tang J, Yao S, Ouyang W, Zhang W, Zuo Y, Wang X, Liu J. Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial. Int J Clin Pharm. 2023 Apr;45(2):473-482. doi: 10.1007/s11096-022-01529-x. Epub 2023 Jan 21.

    PubMed 36680620

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HSK3486 and Propofol in people with Induction of General Anaesthesia, 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 10 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 9 Oct 2018. 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?

The success rate of induction of general 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?

On the ClinicalTrials.gov record for NCT03698617, 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 9 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in