A multicenter, randomized, double-blind, placebo-controlled, and positive-controlled phase II clinical trial was conducted to evaluate the efficacy and safety of HSK55718 injection for postoperative analgesia in patients undergoing abdominal surgery. The primary objective was to evaluate the efficacy of HSK55718 for postoperative analgesia after abdominal surgery. The secondary objective was to evaluate the safety and pharmacokinetic profile of TRD303 solution for postoperative analgesia after abdominal surgery.
Fully understand, voluntarily participate in this study and sign the informed consent;
Age ≥18 years old, both sexes;
Undergo elective abdominal surgery (open or laparoscopic) with a (estimated) duration of ≥1 hour under general anesthesia;
18.0 kg/m2≤ body mass index (BMI) ≤30.0 kg/m2
History of vestibular dysfunction or dizziness, nausea, retching or vomiting within 1 week before screening;
Cardiovascular history: severe superior vena cava obstruction syndrome, severe pericardial effusion, acute myocardial ischemia, unstable angina, myocardial infarction within 6 months before screening, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or history of NYHA class II or above;
Respiratory history: history of severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, throat mass, tracheoesophageal fistula or airway tear, and severe respiratory infection within the last 2 weeks before screening;
History of nervous and mental system: history of craniocerebral injury, convulsion, intracranial hypertension, cerebral aneurysm, cerebrovascular accident, ischemic stroke or transient ischemic attack (TIA); History of schizophrenia, mania, psychosis, long-term use of psychotropic drugs, cognitive dysfunction, etc. Depression, anxiety, epilepsy history, etc.
Yingyong Zhou,MD,PhD
Lead sponsor
The Third Xiangya Hospital of Central South University
Sponsor institution