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.
Parallel
Low dose HSK55718
DrugNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 15mg was given intravenously, and then 7.5mg HSK55718 injection or normal saline was given intermittently every 6 hours
Medium Dose HSK55718
DrugNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 60mg was given intravenously, and then 30mg HSK55718 injection or normal saline was given intermittently every 6 hours.
High dose HSK55718
DrugNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, the first dose of HSK55718 injection 120mg was given intravenously, and then 60mg HSK55718 injection or normal saline was given intermittently every 6 hours
Morphine
DrugNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, morphine injection 2mg was given intravenously as the first dose, and then morphine injection 2mg was given intermittently every 6 hours
Normal saline solution
DrugNRS pain score was performed immediately after emergence from anesthesia. After the postoperative NRS pain score ≥4, normal saline solution was given intravenously as the first dose, and then normal saline solution was given intermittently every 6 hours
The time-weighted summed pain intensity differences over 24 h (SPID0-24 h) at rest
The time-weighted summed pain intensity differences during 0-24 hours (SPID0-24 h) at rest after the first dose
the time-weighted summed pain intensity differences (SPID) at rest
The time-weighted summed pain intensity differences during 0-12h, 12-24h, 24-48h, and 0-48h (SPID0-12h、SPID12-24h、SPID24-48h、SPID0-48h) at rest after the first dose
Pain intensity differences (PID)
The rest pain intensity difference (PID) was calculated at each scoring time point after the first dose, and PID was the difference between the NRS score at each time point and the baseline NRS score
The proportion of NRS pain score ≤3
Time to onset
Maximum Plasma Concentration (Cmax) of HSK55718
Maximum plasma concentration of HSK55718 after Administration
Area under curve (AUC) of the plasma concentration-time during 0-∞ (AUC0-∞)
The total area under the curve (AUC0-∞) at the time of clearance of all prototype drugs from drug administration to day 7 after administration reflects drug absorption and metabolism
Area under curve (AUC) of the plasma concentration-time during 0-t (t=0 to 48h)
The area under the concentration-time curve (AUC0-t, t= 0-48h) from the beginning of administration to time t, and the absorption and metabolism of the reaction drug over time
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Yingyong Zhou,MD,PhD
Lead sponsor
The Third Xiangya Hospital of Central South University
Sponsor institution
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