A multicenter, randomized, double - blind, placebo - controlled, parallel - group phase III clinical trial was carried out to evaluate the efficacy and safety of HRS - 9190 for skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The primary objective was to evaluate the effectiveness of HRS - 9190 in achieving skeletal muscle relaxation during tracheal intubation in the induction and maintenance phases of general anesthesia. The secondary objective was to assess the safety and pharmacokinetic profile of HRS - 9190.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
During the induction phase, 0.6 mg/kg of HRS-9190 was administered intravenously, and during the maintenance phase, 0.2 mg/kg of HRS-9190 was administered intravenously.
During the induction phase, 0.6 mg/kg of rocuronium was administered intravenously, and during the maintenance phase, 0.15 mg/kg of rocuronium was administered intravenously.
The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha, Hunan, China
Proportion of participants with excellent or good intubation conditions at the time of tracheal intubation
Cooper score evaluation of tracheal intubation conditions: excellent, 8 - 9 points; good, 6 - 7 points; fair, 3 - 5 points; poor, 0 - 2 points.
Time frame: From the beginning of the drug to 5 minutes after the administration
Time (minutes) required for the recovery of the myotwitch height value (T1) from 25% until the Train-of-Four ratio (TOFr) reaches ≥90%
Time frame: During the last administration to 2 hours after administration, the TOFr of muscle relaxation monitoring was ≥90%
Time to complete tracheal intubation
Time frame: Time to complete tracheal intubation within 5 minutes after the start of drug administration
Time to onset
Time frame: The time to achieve T1% maximal inhibition was monitored with a muscle relaxometer from the beginning of the dose until 5 min after the dose
Action time
Time from drug administration to T1% recovery onset; time to T1% recovery at 10% and 25%; time from last investigational drug dose to TOFr ≥40%, ≥70%, and ≥90%.
Time frame: Perioperative
Percentage of time T1%≤25%
The percentage of time T1%≤25% in perioperative muscle relaxation monitoring
Time frame: Perioperative
Time from last dose to extubation
Time from last administration to emergence from anesthesia and extubation
Time frame: Perioperative
Anesthesiologist satisfaction score
Satisfaction scores ranged from 0 to 10, with 0 representing dissatisfied and 10 very satisfied
Time frame: From the beginning of administration to 1 hour after the end of surgery
Surgeon satisfaction score
Satisfaction scores ranged from 0 to 10, with 0 representing dissatisfied and 10 very satisfied
Time frame: From the beginning of administration to 1 hour after the end of surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.