Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06332157 |
Other study ID # |
2023-ke-715-1 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 2024 |
Est. completion date |
December 2025 |
Study information
Verified date |
January 2024 |
Source |
Beijing Chao Yang Hospital |
Contact |
Anshi Wu, doctor |
Phone |
010-85231330 |
Email |
wuanshi88[@]163.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
126 patients undergoing general anesthesia for elective surgery in Beijing Chaoyang Hospital
were selected. In the intervention group, anesthesia was induced with remimazolam besylate at
a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by
continuous pump. Control group: anesthesia induction, intravenous injection of propofol
2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients
were routinely monitored for vital signs and anesthesia depth after entering the operating
room. The patients were followed up after surgery, and the quality of recovery score at 24
hours after surgery was the main study outcome.
Description:
This study was a randomized, single-blind, single-center, positive drug controlled,
non-inferiority trial. According to the inclusion and exclusion criteria, 126 patients
undergoing general anesthesia for elective non-cardiac surgery in Beijing Chaoyang Hospital
were selected. In the intervention group, anesthesia was induced with remimazolam besylate at
a rate of 6mg/min; Anesthesia was maintained with 1.0-2.0mg/min remimazolam besylate by
continuous pump. Control group: anesthesia induction, intravenous injection of propofol
2mg/kg; Anesthesia was maintained by continuous pumping of 6-8mg/kg/h propofol. All patients
were routinely monitored for vital signs and anesthesia depth after entering the operating
room. After the patient lost consciousness, routine analgesia and muscle relaxants were
given, followed by tracheal intubation and mechanical ventilation. During the anesthesia
maintenance phase, vital signs and depth of anesthesia were continuously monitored, sedatives
and analgesics were continuously pumped, and muscle relaxants were added intermittently as
needed. The patients were followed up after surgery, and the quality of recovery score at 24
hours after surgery was the main study outcome.