Efficacy and safety of remimazolam besilate for sedation in outpatients undergoing impacted third molar extraction: a prospective exploratory study

被引：9

作者：

Oue, Kana ^{[1
]}

Oda, Aya ^{[1
]}

Shimizu, Yoshitaka ^{[2
]}

Takahashi, Tamayo ^{[1
]}

Kamio, Hisanobu ^{[1
]}

Sasaki, Utaka ^{[1
]}

Imamura, Serika ^{[1
]}

Imado, Eiji ^{[1
]}

Mukai, Akari ^{[2
]}

Doi, Mitsuru ^{[2
]}

Sakuma, Miyuki ^{[3
]}

Ono, Shigehiro ^{[3
]}

Aikawa, Tomonao ^{[3
]}

Yoshida, Mitsuhiro ^{[1
]}

机构：

[1] Hiroshima Univ Hosp, Dept Dent Anesthesiol, Div Oral & Maxillofacial Surg & Oral Med, Kasumi 1 2 3,Minami ku, Hiroshima, Japan

[2] Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Dent Anesthesiol, Kasumi 1 2 3,Minami ku, Hiroshima, Japan

[3] Hiroshima Univ, Grad Sch Biomed & Hlth Sci, Dept Oral & Maxillofacial Surg, Kasumi 1 2 3,Minami ku, Hiroshima, Japan

来源：

BMC ORAL HEALTH | 2023年 / 23卷 / 01期

关键词：

Dental anxiety; Dental fear; Dental procedure; Dental treatment; Remimazolam; Sedation; OBSERVERS ASSESSMENT; CONSCIOUS SEDATION; PROPOFOL SEDATION; MIDAZOLAM; DEXMEDETOMIDINE; PLACEBO; ALERTNESS; TOSILATE; RECOVERY; SCALE;

D O I：

10.1186/s12903-023-03538-2

中图分类号：

R78 [口腔科学];

学科分类号：

1003 ;

摘要：

Background Dental treatments often cause anxiety, fear, and stress in patients. Intravenous sedation is widely used to alleviate these concerns, and various agents are employed for sedation. However, it is important to find safer and more effective sedation agents, considering the adverse effects associated with current agents. This study aimed to investigate the efficacy and safety of remimazolam besilate (hereinafter called "remimazolam") and to determine the optimal dosages for sedation in outpatients undergoing dental procedures.Methods Thirty-one outpatients aged 18-65 years scheduled for impacted third molar extraction were included in the study. Remimazolam was administered as a single dose of 0.05 mg/kg followed by a continuous infusion at a rate of 0.35 mg/kg/h, with the infusion rate adjusted to maintain a sedation level at a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score of 2-4. The primary endpoint was the sedation success rate with remimazolam monotherapy, and the secondary endpoints included induction time, recovery time, time until discharge, remimazolam dose, respiratory and circulatory dynamics, and frequency of adverse events.Results The sedation success rate with remimazolam monotherapy was 100%. The remimazolam induction dose was 0.08 (0.07-0.09) mg/kg, and the anesthesia induction time was 3.2 (2.6-3.9) min. The mean infusion rate of remimazolam during the procedure was 0.40 (0.38-0.42) mg/kg/h. The time from the end of remimazolam administration to awakening was 8.0 (6.7-9.3) min, and the time from the end of remimazolam administration to discharge was 14.0 (12.5-15.5) min. There were no significant respiratory or circulatory effects requiring intervention during sedation.Conclusions Continuous intravenous administration of remimazolam can achieve optimal sedation levels without significantly affecting respiratory or circulatory dynamics. The study also provided guidance on the appropriate dosage of remimazolam for achieving moderate sedation during dental procedures. Additionally, the study findings suggest that electroencephalogram monitoring can be a reliable indicator of the level of sedation during dental procedural sedation with remimazolam.

引用

页数：12

共 51 条

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