A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia (NCT04511728) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluate the Efficacy and Safety of HSK3486 in the Induction of General Anesthesia
China129 participantsStarted 2020-11-24
Plain-language summary
This is a multi-center, randomized, single-blind, propofol injectable emulsion parallel-controlled Phase III clinical study. A total of patients undergoing elective surgery are intended to be enrolled and randomly assigned to HSK3486 group and propofol group in a 2:1 ratio.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. In-patients undergoing non-emergency, non-cardiothoracic, and non-extracerebral elective surgeries with expected operation time ≥ 1 h and requiring tracheal intubation under general anesthesia (patients whose surgery type may affect the collection of BIS parameter should not be included);
✓. Male or female, age ≥ 18 and ≤ 65 years old;
✓. American Society of Anesthesiologists (ASA) class I-III;
✓. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2;
✓. Vital signs in the screening period meeting the following criteria:
✓. Respiration rate ≥ 10 and ≤ 24 breaths/min;
✕. Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
✕. Known hypersensitivity to excipients and ingredients found in propofol injection and HSK3486 injectable emulsion (soybean oil, glycerin, triglycerides, egg lecithin, sodium oleate, and sodium hydroxide), benzodiazepines, opioids, rocuronium bromide, and sugammadex sodium; cross-reactivity to halogenated anesthetics, jaundice or unexplained fever from previous use of halogenated anesthetics; contraindications to propofol;
✕. The following disease history or evidence that increases the risk of sedation/anesthesia is collected before/during screening:
What they're measuring
1
Success rate of anesthesia maintenance
Timeframe: During maintenance of general anesthesia on day 1
✕. History of cardiovascular diseases: uncontrolled hypertension or SBP \> 160 mmHg and/or DBP \> 100 mmHg after treatment with antihypertensive drugs, severe arrhythmia, heart failure, Adams-Stokes syndrome, unstable angina, myocardial infarction, tachycardia/bradycardia requiring medication, or third-degree atrioventricular block within 6 months before screening, or QTcF interval of ≥ 450 ms (corrected using Fridricia's formula) during the screening period;
✕. History of respiratory diseases: respiratory insufficiency, history of obstructive pulmonary disorders, history of bronchospasm requiring treatment within 3 months before screening, and acute respiratory infection with one of the symptoms such as obvious fever, wheezing or productive cough within 1 week before the baseline period;
✕. History of neurological and psychiatric disorders: craniocerebral injury, convulsions, epilepsy, intracranial hypertension, cerebral aneurysms, cerebrovascular accidents; or schizophrenia, mania, long-term use of psychotropic drugs, history of cognitive impairment, etc.;
✕. History of gastrointestinal tract diseases: gastrointestinal retention, active bleeding, gastroesophageal reflux or obstruction, etc. which may cause reflux and aspiration judged by the investigator;
✕. Diabetic patients with uncontrolled blood glucose (fasting blood glucose ≥ 11.1 mmol/L, and/or random blood glucose ≥ 13.6 mmol/L);