A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486 (NCT03698617) | Clinical Trial Compass
CompletedPhase 2
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
China114 participantsStarted 2016-12-06
Plain-language summary
This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Inpatients required tracheal intubation under general anesthesia and a non-emergency non-cardiothoracic and non-extracranial elective surgery for an estimated duration of ≤ 3 h ;.
✓. Males or females, aged ≥ 18 and ≤ 65 years old;
✓. Body mass index (BMI) ≥ 19 and ≤ 30 kg/m2;
✓. ASA grade I\~II;
✓. Capable of understanding the procedure and method of this study, willing to sign an informed consent form and to complete this study in strict accordance with the study protocol.
Exclusion criteria
✕. Patients were contraindicated in general anesthesia.;
✕. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated
✕. Patients in receipt of any investigational drug within 30 days before screening.
✕. Patients in receipt of propofol, opioid , other sedative or anesthetic or analgesics within one month prior to the screening period.
✕. Patients in receipt of general anesthesia surgery within two weeks prior to the screening period.
✕. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, liver, kidney, blood system, or metabolic system disease prior to the screening period.
What they're measuring
1
The success rate of induction of general anesthesia
Timeframe: during induction of general anesthesia on day 1
Trial details
NCT IDNCT03698617
SponsorSichuan Haisco Pharmaceutical Group Co., Ltd