A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Su… (NCT04048811) | Clinical Trial Compass
CompletedPhase 2
A Clinical Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Elective Surgery Patients
China46 participantsStarted 2019-12-09
Plain-language summary
This is a multi-center, randomized, open-label, positive-controlled (propofol) phase II clinical trial. The study plans to enroll approximately 46 eligible subjects. Among them, 40 subjects will be randomly assigned to HSK3486 treatment group (30 cases) and propofol control group (10 cases) in a ratio of 3:1. The subjects will be enrolled competitively at all study sites. Upon enrollment of the 40 subjects, 6 more subjects will be enrolled by West China Hospital of Sichuan University. These 6 subjects will not be randomized, but will directly enter into propofol induction + HSK3486 maintenance group for study.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Inpatients requiring tracheal intubation under general anesthesia and a non-emergent, non-cardiothoracic, non-extracerebral, and non-nasal endoscopic elective surgery for an estimated duration of about 1-6 h, with an bleeding volume of ≤ 1000 mL
✓. Aged ≥ 18 and ≤ 65 years old, regardless of gender;
✓. American Society of Anesthesiologists (ASA) Class I-III;
✓. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2;
✓. The vital signs during the screening period meet the following criteria:
✓. The laboratory parameters measured at screening period reach the following criteria:
✓. Subjects who understand the procedures and methods of this study, and are willing to complete the trial in strict accordance with clinical trial protocol and sign the informed consent.
Exclusion criteria
✕. Patients with contraindications to general anesthesia or previous history of anesthesia accidents;
What they're measuring
1
Success rate of anesthesia maintenance
Timeframe: During maintenance of general anesthesia on day 1
2
Number of patients with adverse events
Timeframe: Pre-dose to 48 hours post-dose
Trial details
NCT IDNCT04048811
SponsorSichuan Haisco Pharmaceutical Group Co., Ltd
. 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;
✕. Medical history or evidence of any of the following prior to screening, which may increase sedation/anesthesia risk:
✕. Any one of the following respiratory risks before/during screening:
✕. Received any of the following drugs or therapies prior to screening:
✕. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Subjects who are planning pregnancy within 1 month after the completion of the trial (including male subjects);
✕. Subjects judged by the investigator to be unsuitable for participating in this trial for any reason.