A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects

NCT03808844 | Completed Phase 3 DMC

• 1 other identifier: HSK3486-302
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Anesthesia

Outcome Measures

Primary Outcomes (1)

• The success rate of induction of anesthesia

  During induction of general anesthesia on day 1

Secondary Outcomes (6)

• 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

• Use of the investigational drug and alternative drugs

  During induction of general anesthesia on day 1

• Use of the alternative drugs

  During induction of general anesthesia on day 1

• Changes in bispectral index (BIS)（score：0~100）

  During induction of general anesthesia on day 1

Study Arms (2)

HSK3486

EXPERIMENTAL

0.4mg/kg/0.2 mg/kg

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

2.0mg/kg/1.0mg/kg

Drug: Propofol

Interventions

HSK3486 DRUG

Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed.

HSK3486

Propofol DRUG

Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed

Propofol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, China

Location

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 18, 2019
• Study Start: March 22, 2019
• Primary Completion: August 14, 2019
• Study Completion: September 3, 2019
• Last Updated: September 13, 2019

Record last verified: 2018-12

Locations

CN (1)