Moderate sedation by total intravenous remimazolam-alfentanil vs. propofol-alfentanil for third molar extraction: A prospective randomized controlled trial

Abstract

BackgroundOral 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.MethodsThis 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.ResultsThe 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); P < 0.05], with no serious adverse events during the sedation procedure. The incidence of injection pain in group RA was significantly lower than that in group PA [4 vs. 26%, mean difference 0.119 (95%CI, 0.025–0.558); P = 0.004]. Before starting local anesthesia, the mean arterial pressure, heart rate, and respiratory rate of the PA group were lower than those of the RA group. None of the patients required further treatments for a decreased heart rate, blood pressure, or low SpO2. The rate of moderate sedation success was 100% in both groups. The MOAA/S score was similar between the groups indicating that the depth of sedation was effective. Group RA had significantly shorter recovery and discharge times than those of group PA.ConclusionsRemimazolam 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 registrationhttp://www.chictr.org.cn/index.aspx, identifier: ChiCTR2200058106.

Efficacy of continuous intravenous remimazolam versus midazolam in the extraction of impacted wisdom teeth: protocol of a randomised controlled trial

“… 17 18 Remimazolam combined with opioid analgesics can be used for ambulatory sedation. 19 Phase III clinical studies of this agent have used remimazolam in colonoscopy, 20 fibrobronchoscopy 21 and for the induction and maintenance of general anaesthesia. 22 23 These studies show that when compared with other similar products, remimazolam exhibited a quick action onset, rapid metabolism and no accumulation.…”

Safety and effectiveness of the combination of remimazolam tosilate and propofol in gastroscopy: a multicenter, randomized controlled, single-blind clinical trial

“…Previous studies confirmed that RT could be safely and effectively used for sedation in outpatient surgeries, such as gastrointestinal endoscopy (Rex et al, 2018;Lu et al, 2022;Xin et al, 2022), bronchoscopy (Pastis et al, 2019), tooth extraction (Zhao et al, 2022), hysteroscopy (Zhang et al, 2021), or induction and maintenance of general anesthesia (Zhou et al, 2020;Mao et al, 2022). RT could also provide enough sedative effect and safety for special patients, such as elderly patients (Liu et al, 2022;Tan et al, 2022) and patients with liver cirrhosis (Cao et al, 2022).…”

“…Some studies ( Antonik et al, 2012 ; Zhou et al, 2015 ) proved the varied advantages of RT, such as rapid-onset, controllable inhibition of cardiovascular and respiratory systems, inactive metabolites through plasma esterase metabolism, low potential of drug interaction, and reversibility. Therefore, it can be used for sedation outside the operating room, such as bronchoscopy ( Pastis et al, 2019 ), hysteroscopy ( Zhang et al, 2021 ), molar extraction ( Zhao et al, 2022 ), and other endoscopic examinations ( Rex et al, 2018 ).…”

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

“…There are currently few research reports that have evaluated the efficacy and safety of remimazolam for sedation during dental procedures. A single-center, randomized, single-blind clinical trial with alfentanil in adults undergoing outpatient third molar extractions reported a lower incidence of adverse events, significantly lower incidence of injection pain, and significantly shorter recovery and discharge times in the remimazolam group compared to the propofol group [ 35 ]. Another prospective, randomized, controlled, single-center trial of 40 patients undergoing outpatient oral surgery in China found that the remimazolam group had a significantly higher sedation success rate and faster recovery compared to the midazolam group [ 36 ].…”