Comparison of recovery profiles between total intravenous anaesthesia with propofol or remimazolam reversed with flumazenil in patients undergoing breast surgery: A randomised controlled trial.
Journal
European journal of anaesthesiology
ISSN: 1365-2346
Titre abrégé: Eur J Anaesthesiol
Pays: England
ID NLM: 8411711
Informations de publication
Date de publication:
12 Jan 2024
12 Jan 2024
Historique:
medline:
11
1
2024
pubmed:
11
1
2024
entrez:
11
1
2024
Statut:
aheadofprint
Résumé
Remimazolam, a short acting benzodiazepine, is being used for general anaesthesia. The results of studies comparing recovery after propofol with that of remimazolam are inconsistent. Given that flumazenil reverses the sedative effects of remimazolam, we hypothesised that it would speed up recovery from remimazolam general anaesthesia. The aim of this trial was to compare the speed of recovery from general anaesthesia between propofol and remimazolam reversed with flumazenil in patients undergoing minimally invasive breast surgery. Randomised, single-centre, double-blind controlled trial. A tertiary teaching hospital in South Korea from August 2022 to December 2022. Adult patients (≥19 years of age) about to undergo general anaesthesia for scheduled breast cancer surgery. Patients were randomly allocated to either the propofol or the remimazolam/flumazenil group. The emergence process was monitored by only one anaesthesiologist. The primary outcome was the time to eye opening to command during recovery from the general anaesthesia. Time to removal of the supraglottic airway (SGA) time to discharge, and the Riker sedation agitation scale (SAS) score (1 to 4) during emergence were compared as secondary outcomes. The remimazolam group had a significantly shorter mean time to eye opening than the propofol group [127 ± 51 vs. 314 ± 140 s; mean difference 187 s (95% confidence interval (CI), 133 to 241 s; P < 0.001]. The remimazolam group also had shorter times to SGA removal [169 ± 51 vs. 366 ± 149 s; mean difference 198 s (95% CI, 140 to 255 s); P < 0.001] and time to discharge from the operating room [243 ± 55 vs. 449 ± 159 s; mean difference 206 s (95% CI, 145 to 267 s); P < 0.001]. The SAS scores during emergence also differed significantly, with 1 patient in the propofol group and 25 in the remimazolam group attaining scores of 4 (P < 0.001). Administration of remimazolam with flumazenil may be a promising option for patients undergoing breast cancer surgery, providing faster recovery and better SAS scores than propofol during emergence from general anaesthesia. ClinicalTrials.gov (NCT05435911).
Sections du résumé
BACKGROUND
BACKGROUND
Remimazolam, a short acting benzodiazepine, is being used for general anaesthesia. The results of studies comparing recovery after propofol with that of remimazolam are inconsistent. Given that flumazenil reverses the sedative effects of remimazolam, we hypothesised that it would speed up recovery from remimazolam general anaesthesia.
OBJECTIVES
OBJECTIVE
The aim of this trial was to compare the speed of recovery from general anaesthesia between propofol and remimazolam reversed with flumazenil in patients undergoing minimally invasive breast surgery.
DESIGN
METHODS
Randomised, single-centre, double-blind controlled trial.
SETTING
METHODS
A tertiary teaching hospital in South Korea from August 2022 to December 2022.
PATIENTS
METHODS
Adult patients (≥19 years of age) about to undergo general anaesthesia for scheduled breast cancer surgery.
INTERVENTIONS
METHODS
Patients were randomly allocated to either the propofol or the remimazolam/flumazenil group. The emergence process was monitored by only one anaesthesiologist.
MAIN OUTCOME MEASURES
METHODS
The primary outcome was the time to eye opening to command during recovery from the general anaesthesia. Time to removal of the supraglottic airway (SGA) time to discharge, and the Riker sedation agitation scale (SAS) score (1 to 4) during emergence were compared as secondary outcomes.
RESULTS
RESULTS
The remimazolam group had a significantly shorter mean time to eye opening than the propofol group [127 ± 51 vs. 314 ± 140 s; mean difference 187 s (95% confidence interval (CI), 133 to 241 s; P < 0.001]. The remimazolam group also had shorter times to SGA removal [169 ± 51 vs. 366 ± 149 s; mean difference 198 s (95% CI, 140 to 255 s); P < 0.001] and time to discharge from the operating room [243 ± 55 vs. 449 ± 159 s; mean difference 206 s (95% CI, 145 to 267 s); P < 0.001]. The SAS scores during emergence also differed significantly, with 1 patient in the propofol group and 25 in the remimazolam group attaining scores of 4 (P < 0.001).
CONCLUSION
CONCLUSIONS
Administration of remimazolam with flumazenil may be a promising option for patients undergoing breast cancer surgery, providing faster recovery and better SAS scores than propofol during emergence from general anaesthesia.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov (NCT05435911).
Identifiants
pubmed: 38205822
doi: 10.1097/EJA.0000000000001951
pii: 00003643-990000000-00158
doi:
Banques de données
ClinicalTrials.gov
['NCT05435911']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 European Society of Anaesthesiology and Intensive Care. Unauthorized reproduction of this article is prohibited.
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