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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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.