Efficacy and safety of remimazolam for induction and maintenance of general anesthesia in day surgery: a randomized controlled non-inferiority clinical trial.

Background: Remimazolam is a novel ultrashort-acting benzodiazepine anesthetic demonstrated to be safe and effective for painless gastroscopy and bronchoscopy. However, research on the application of remimazolam in general anesthesia for short day surgery is relatively limited. This study aimed to evaluate the efficacy and safety of remimazolam for both the induction and maintenance of general anesthesia in short day surgery.

Method: One hundred patients who underwent elective surgery were randomly divided into two groups: the Propofol group and the Remimazolam group. The primary outcomes consisted of the rates of successful anesthesia, defined by the absence of intraoperative awareness, the need for additional sedatives, and any involuntary limb movements, along with the incidence of life-threatening adverse events. The secondary outcomes included mean arterial pressure (MAP), heart rate (HR), time to loss of consciousness (LOC), injection pain, administration of vasopressors, time to extubation and eye opening, length of PACU stay, VAS score, and occurrence of postoperative adverse reactions.

Results: The anesthesia efficacy was 100% in both groups. However, the time to LOC in the Propofol group was shorter than that in the Remimazolam group (P < 0.01). Compared with the Remimazolam group, the Propofol group presented a significant decrease in HR and MAP at the time of LOC (P < 0.05) and a significant decrease in MAP at 30 min after the start of surgery (P < 0.05). The use of vasopressors and the incidence of injection pain were significantly greater in the Propofol group than in the Remimazolam group (P < 0.05).

Conclusion: Compared with propofol, when the antagonist flumazenil is not used, remimazolam is not inferior to propofol in terms of safety and efficacy in the induction and maintenance of anesthesia for short daytime surgeries, and it does not cause delayed discharge of patients or increase postoperative adverse reactions.

Trial registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR2400088335, registration date: August 15, 2024).