Moderate sedation by total intravenous remimazolam-alfentanil vs. propofol-alfentanil for third molar extraction: A prospective randomized controlled trial.
alfentanil
propofol
remimazolam
sedation
third molar
Journal
Frontiers in medicine
ISSN: 2296-858X
Titre abrégé: Front Med (Lausanne)
Pays: Switzerland
ID NLM: 101648047
Informations de publication
Date de publication:
2022
2022
Historique:
received:
29
07
2022
accepted:
17
08
2022
entrez:
19
9
2022
pubmed:
20
9
2022
medline:
20
9
2022
Statut:
epublish
Résumé
Oral dental treatment cause anxiety, fear, and physical stress. This study aimed to investigate the efficacy and safety of moderate sedation by remimazolam with alfentanil vs. propofol with alfentanil in third molar extraction. This single-center, randomized, single-blind clinical trial included 100 adults who underwent third molar ambulatory extraction. All patients had continuous infusion of Alfentanil 0.2 μg/kg/min. Group remimazolam with alfentanil (group RA) had an induction dose of 80 μg/kg and maintenance dosage of 5 μg/kg/min. In group propofol with alfentanil (PA group), propofol was infused at an initial concentration of 1.8 μg/mL under target controlled infusion (TCI) mode and a maintenance concentration of 1.5 μg/mL. The incidence rates of adverse effects were recorded and compared. Depth of sedation was assessed using the modified observer alertness/sedation assessment (MOAA/S) and entropy index. Recovery characteristics were recorded and complications observed for next 24 h. The incident of adverse events 6 (12%) in the group RA was lower than the group PA 25 (50%) [Mean difference 0.136 (95%CI, 0.049-0.377); Remimazolam with alfentanil is a safer and more effective alternative for ambulatory sedation and can reduce recovery and discharge time and the incidence of perioperative adverse events compare with propofol. http://www.chictr.org.cn/index.aspx, identifier: ChiCTR2200058106.
Sections du résumé
Background
UNASSIGNED
Oral dental treatment cause anxiety, fear, and physical stress. This study aimed to investigate the efficacy and safety of moderate sedation by remimazolam with alfentanil vs. propofol with alfentanil in third molar extraction.
Methods
UNASSIGNED
This single-center, randomized, single-blind clinical trial included 100 adults who underwent third molar ambulatory extraction. All patients had continuous infusion of Alfentanil 0.2 μg/kg/min. Group remimazolam with alfentanil (group RA) had an induction dose of 80 μg/kg and maintenance dosage of 5 μg/kg/min. In group propofol with alfentanil (PA group), propofol was infused at an initial concentration of 1.8 μg/mL under target controlled infusion (TCI) mode and a maintenance concentration of 1.5 μg/mL. The incidence rates of adverse effects were recorded and compared. Depth of sedation was assessed using the modified observer alertness/sedation assessment (MOAA/S) and entropy index. Recovery characteristics were recorded and complications observed for next 24 h.
Results
UNASSIGNED
The incident of adverse events 6 (12%) in the group RA was lower than the group PA 25 (50%) [Mean difference 0.136 (95%CI, 0.049-0.377);
Conclusions
UNASSIGNED
Remimazolam with alfentanil is a safer and more effective alternative for ambulatory sedation and can reduce recovery and discharge time and the incidence of perioperative adverse events compare with propofol.
Clinical trial registration
UNASSIGNED
http://www.chictr.org.cn/index.aspx, identifier: ChiCTR2200058106.
Identifiants
pubmed: 36117971
doi: 10.3389/fmed.2022.950564
pmc: PMC9479102
doi:
Types de publication
Journal Article
Langues
eng
Pagination
950564Informations de copyright
Copyright © 2022 Zhao, Zeng, Fan, Wang, Zhang, Zou, Zhang, Li and Yu.
Déclaration de conflit d'intérêts
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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