Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial

Abstract

Background: Remimazolam (Rm) is a novel ultra-short-acting benzodiazepine used in general anesthesia. However, its application in pediatric general anesthesia remains limited. This study aims to compare the efficacy, safety, and postoperative emergence profiles of remimazolam and propofol (Pf) in pediatric surgical anesthesia.

Methods: Children (aged 3-12 years) undergoing strabismus correction surgery were randomly assigned to the Group Rm or the Group Pf. The Group Rm and Group Pf received an induction dose of 0.3 mg/kg and 2 mg/kg, respectively. For emergence, the Group Rm was administered flumazenil 0.2-0.3 mg. The primary outcome was the time from the discontinuation of anesthetic agents to the first eye opening. Secondary outcomes included the time from the end of surgery to laryngeal mask airway (LMA) removal, the time to achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 5 after LMA removal, and Aldrete scores during the postanesthetic care unit (PACU) stay. Additionally, the changes of vital signs before and after anesthesia were compared between the two groups.

Results: In all patients, both remimazolam and propofol induced anesthesia successfully. Regarding emergence profiles, the Group Rm had significantly shorter times to first eye opening, LMA removal, and achieving an MOAA/S score of 5 post-LMA removal compared to the Group Pf (p < 0.001). Upon arrival at the PACU, the number of patients with Aldrete scores ≥ 9 was significantly higher in the Group Rm (p < 0.001). Following injection, the reduction in DBP was significantly greater in the Group Pf compared to the Group Rm (p < 0.001). The Group Rm maintained a more stable HR compared to the Group Pf.

Conclusion: Remimazolam provides more stable hemodynamic characteristics and significantly shorter postoperative emergence time in pediatric patients compared to propofol. This suggests that remimazolam may be more suitable than propofol for pediatric general anesthesia, though larger scale clinical trials are needed for further validation.

Trial registration: Chinese Clinical Trial Registry, ChiCTR2400083265.

Keywords: Emergence profiles; Hemodynamics; Pediatric anesthesia; Propofol; Remimazolam.

Fig. 1

Flow diagram of the study

Fig. 2

Effects of remimazolam and propofol on SBP, DBP, HR, and SpO₂. ^*p < 0.05, ^**p < 0.01, ^***p < 0.001 for T0 versus T1, T2, T3, and T4 in Group Rm or Pf. ^#p < 0.05, ^##p < 0.01, ^###p < 0.001 for the Group Pf versus Group Rm