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Efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients: a multicenter, randomized, open-label, propofol-controlled phase 2 Clinical trial HSK3486 for the efficacy and safety of induction and maintenance of general anesthesia in patients undergoing elective surgery: a multicenter, randomized, open-label, propofol controlled Phase 2 clinical trial
Abstract OBJECTIVE:01
1 Trial flow chart
, Fig.
2 Changes
in BIS values during anesthesia induction and maintenance Table 1: Baseline characteristics
, Table 2, Effectiveness outcome
table, Table 3 Adverse events
Abstract OBJECTIVE:01
To evaluate the efficacy and safety of HSK3486 for the induction and maintenance of general anesthesia in elective surgical patients, but excluding emergency, cardiothoracic, cerebral and endoscopic sinus cases.
Abstract-Objective: To evaluate the efficacy and safety of HSK3486 for induction and maintenance of general anesthesia in patients undergoing elective surgery, excluding emergency surgery, cardiothoracic surgery, craniocerebral surgery and endoscopic sinus surgery
.
A total of 40 eligible patients were randomly assigned to HSK3486 (n = 30) or propofol (n = 10) dosage groups in a ratio of 3:1.
Drugs were administered as a bolus injection of 0.
4 mg/kg (HSK3486) or 2.
0 mg/kg (propofol) for induction, followed by maintenance infusion with the same anesthetic.
An additional 6 non-randomized patients received propofol (2.
0 mg/kg) for induction and were given HSK3486 for maintenance.
Patients and Methods: A total of 40 eligible patients were randomized to HSK3486 (n=30) or propofol (n=10), with a 3:1
ratio of patients in both groups.
General anesthesia induction is performed using HSK3486 at 0.
4 mg/kg or propofol at 2.
0 mg/kg, followed by infusion of the same drug for general anesthesia maintenance
.
Another 6 non-randomized patients received propofol 2.
0 mg/kg for general anesthesia induction and HSK3486 for general anesthesia maintenance
.
The primary efficacy endpoint – the success rate of anesthesia maintenance – was 100% in the 3 arms.
The secondary efficacy endpoints included times from discontinuation of HSK3486 or propofol maintenance to full alertness, respiratory recovery, extubation and reaching the goal of the Aldrete score.
Also, the proportion of patients who constantly maintained BIS40-60 or those with a period of BIS40-60 during maintenance anesthesia showed no significant difference in the HSK3486 and propofol
groups (all p > 0.
05).
Patients who received HSK3486 exhibited a higher satisfaction score from anesthesiologists during the induction period (p = 0.
024).
The
occurrence and types of treatment-emergent adverse events were similar among the 3 arms, both with a severity of grade 1 or 2.
Drug-related hypotension occurred in 14 (46.
7%) and 7 (70.
0%) patients treated with HSK3486 and propofol, respectively.
Results: The success rate of general anaesthesia maintenance was 100%
in the primary efficacy endpoint of all three study groups.
Secondary efficacy endpoints included time from discontinuation (HSK3486 or propofol) to full awakening, respiratory recovery, extubation, and achievement of the Aldrete target score
.
There was no significant difference between HSK3486 and propofol (all p>0.
05
) in the proportion of patients who maintained BIS 40-60 or BIS 40-60 during general anesthesia maintenance.
During the induction phase of general anesthesia, the satisfaction score of anesthesiologists in the HSK3486 group was higher (p=0.
024).
The incidence and type of adverse events were similar in the three study groups, with adverse events of grade 1 or 2 severity
.
In the HSK3486 group and propofol group, 14 (46.
7%) and 7 (70.
0%) patients developed drug-related hypotension
, respectively.
HSK3486 exhibited good efficacy for the induction and maintenance of general anesthesia and was well tolerated by patients who underwent elective surgery.
Conclusion: HSK3486 has good efficacy in induction and maintenance of general anesthesia, and HSK3486 is well tolerated
in patients undergoing elective surgery.
1 Trial flow chart
, Fig.
2 Changes
in BIS values during anesthesia induction and maintenance Table 1: Baseline characteristics
, Table 2, Effectiveness outcome
table, Table 3 Adverse events
