A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of Ge… (NCT03808844) | Clinical Trial Compass
CompletedPhase 3
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion for the Induction of General Anesthesia in Elective Surgery Subjects
China178 participantsStarted 2019-03-22
Plain-language 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.
Who can participate
Age range18 Years – 64 Years
SexALL
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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:
What they're measuring
1
The success rate of induction of anesthesia
Timeframe: During induction of general anesthesia on day 1
Trial details
NCT IDNCT03808844
SponsorSichuan Haisco Pharmaceutical Group Co., Ltd
. 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;