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 (P...

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Main Authors: Jinling Qin, Wei Gan, Qun Liu, Xiaolin Zhang, Xiaoyu Li, Bo Lu, Qing Shen
Format: Article
Language:English
Published: BMC 2025-04-01
Series:BMC Anesthesiology
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Online Access:https://doi.org/10.1186/s12871-025-03050-w
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author Jinling Qin
Wei Gan
Qun Liu
Xiaolin Zhang
Xiaoyu Li
Bo Lu
Qing Shen
author_facet Jinling Qin
Wei Gan
Qun Liu
Xiaolin Zhang
Xiaoyu Li
Bo Lu
Qing Shen
author_sort Jinling Qin
collection DOAJ
description 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.
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spelling doaj-art-9e2fd631dff445f4b195fb46e142aafe2025-08-20T02:55:29ZengBMCBMC Anesthesiology1471-22532025-04-012511910.1186/s12871-025-03050-wEmergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trialJinling Qin0Wei Gan1Qun Liu2Xiaolin Zhang3Xiaoyu Li4Bo Lu5Qing Shen6Department of AnesthesiologyDepartment of Anesthesiology, Ningbo Aier Guangming Eye HospitalDepartment of Anesthesiology, Ningbo Aier Guangming Eye HospitalDepartment of Anesthesiology, Ningbo Aier Guangming Eye HospitalDepartment of AnesthesiologyDepartment of AnesthesiologyDepartment of AnesthesiologyAbstract 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.https://doi.org/10.1186/s12871-025-03050-wRemimazolamPropofolPediatric anesthesiaEmergence profilesHemodynamics
spellingShingle Jinling Qin
Wei Gan
Qun Liu
Xiaolin Zhang
Xiaoyu Li
Bo Lu
Qing Shen
Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
BMC Anesthesiology
Remimazolam
Propofol
Pediatric anesthesia
Emergence profiles
Hemodynamics
title Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
title_full Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
title_fullStr Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
title_full_unstemmed Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
title_short Emergence profiles of remimazolam-flumazenil versus propofol in pediatric general anesthesia for strabismus correction: a randomized clinical trial
title_sort emergence profiles of remimazolam flumazenil versus propofol in pediatric general anesthesia for strabismus correction a randomized clinical trial
topic Remimazolam
Propofol
Pediatric anesthesia
Emergence profiles
Hemodynamics
url https://doi.org/10.1186/s12871-025-03050-w
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