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

Sichuan Haisco Pharmaceutical Group Co., Ltd1 site in 1 country178 target enrollmentMarch 22, 2019

ConditionsInduction of Anesthesia

InterventionsPropofol HSK3486

DrugsHSK3486 Propofol

Overview

Phase: Phase 3
Intervention: Propofol
Conditions: Induction of Anesthesia
Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
Enrollment: 178
Locations: 1
Primary Endpoint: The success rate of induction of anesthesia
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 22, 2019

End Date

September 3, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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;
•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;

Arms & Interventions

Propofol

2.0mg/kg/1.0mg/kg

Intervention: Propofol

HSK3486

0.4mg/kg/0.2 mg/kg

Intervention: HSK3486

Outcomes

Primary Outcomes

The success rate of induction of anesthesia

Time Frame: During induction of general anesthesia on day 1

Secondary Outcomes

Use of the alternative drugs(During induction of general anesthesia on day 1)
Use of the investigational drug and alternative drugs(During induction of general anesthesia on day 1)
Number of patients with adverse events(Pre-dose to 48 hours post-dose)
Changes in bispectral index (BIS)（score：0~100）(During induction of general anesthesia on day 1)
Time to successful anesthetic induction(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(From the initial administration of the investigational drug to loss of eyelash reflex on day 1)