Success Rate Of Sedation Research Articles

Dexmedetomidine for electroencephalogram in children with behavioural disorders: a comparative study between intranasal and intravenous administration

ObjectiveThe aim of the project was to compare the efficacy and safety of intranasal (IN) and intravenous (IV) dexmedetomidine (DEX) in procedural sedation for electroencephalogram (EEG) in paediatric patients with behavioural disorders.MethodsSingle-centre comparative observational study in the tertiary care centre of Padua, regarding all consecutive patients < 18 years old affected by behavioural disorders, who needed sedation for EEG recording. From 2018 to 2019 a group of children received IV administration of DEX, from 2020 to 2021 a second group of children received IN administration of the same drug. In both groups, the target of sedation was level 2, in accordance with the Paediatric Sedation State Scale (PSSS). Heart rate (HR), pulse oxygen saturation and blood pressure (BP) were registered. The quality of the EEG recordings and the satisfaction of caregivers were collected.ResultsDEX was used in 48 patients (IV = 24; IN = 24) with total sedation success rate of 98%. Only one patient failed with IN DEX. IN DEX showed longer median onset time (p < 0.01), but shorter offset (p = 0.01) than IV route. All adverse effects were self-resolved. The IN group reported 9 cases of bradycardia, while hypotension and hypertension occurred in the IV group. EEG recording quality and level of satisfaction among caregivers and EEG technicians were high in both groups.ConclusionsIN DEX is an effective sedative; its recovery time shorter than IV DEX and its favourable adverse events profile make this route a reasonable alternative, especially in paediatric patients with a low compliance to procedures.

The efficacy and safety of remimazolam in painless colonoscopy: a prospective, randomized clinical trial.

Remimazolam is a new type of ultra-short-effect intravenous anesthetic, that may provide adequate sedation for endoscopy while causing less cardiovascular or respiratory disturbance than propofol. The aim of this clinical study was to compare the efficacy and safety of two different doses of remimazolam with propofol for sedation during colonoscopy. 225 subjects, aged 18 to 80 years, with American Society of Anesthesiology physical status I-III, were scheduled to undergo colonoscopy. All the subjects were randomly assigned to three groups, Low-Rem group (low dose remimazolam, 0.15 mg/kg, iv, n = 75), High-Rem group (high dose remimazolam, 0.2 mg/kg, iv, n = 75), and Propofol group (propofol 2 mg/kg, iv, n = 75). Every individual in this trial was given nalbuphine hydrochloride (0.2 mg/kg, iv) before administration of remimazolam or propofol. The primary outcome was the success rate of sedation. Haemodynamic parameters and adverse events were recorded to evaluate safety. Satisfaction of sedation from patients, anesthesiologists and gastroenterologists were also recorded. The success rate of colonoscopy procedure was 100% in both High-Rem and Propofol groups, but it was 89% in Low-Rem group (p < 0.05). Furthermore, the induction time of anesthesia was shorter in Propofol group, when compared to the Low-Rem group and the High-Rem group (p < 0.05). The recovery time in Low-Rem group, High-Rem group, and Propofol group was 2.33, 2.43, and 3.21 min (p < 0.05) respectively, and the time of discharge was 25.00, 25.01, and 27.56 min (p < 0.05) respectively. Simultaneously, the incidence of adverse events such as hypotension, bradycardia, and respiratory depression in the remimazolam groups were significantly lower than that in the propofol group. No significant differences were observed among the three groups in Ramsay scale, BPS-NI scale, and Limb movement classification. Moreover, patients, anesthesiologists, and gastroenterologists were all satisfied with the sedation process. Remimazolam can be used safely and effectively for colonoscopy. 0.2 mg/kg remimazolam and propofol have the same sedation success rate and more stable hemodynamics and fewer side effects than propofol. ChiCTR2100054053.

The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial

BackgroundStudies have reported that ciprofol has the advantage of reducing injection pain compared to propofol during gastroscopy, colonoscopy, and fiberoptic bronchoscopy. The effect of ciprofol on the injection pain in painless hysteroscopy needs to further explore.MethodsA double-blind randomized controlled trial (RCT) was designed, and patients were recruited from the First Central Hospital of Baoding from March 2024 to June 2024. The eligible participants were allocated into ciprofol group (ciprofol combined with alfentanil) and propofol group (propofol combined with alfentanil) at 1:1 ratio. The primary outcome was injection pain. The secondary outcomes included sedation success rate, anesthesia success rate, adverse events, patient satisfaction, and comparison of vital signs before and after administration.ResultsA total of 217 participants were included for analysis, with 109 participants in the ciprofol group and 108 participants in the propofol group. The injection pain rate of ciprofol group (18.35%) was significantly lower than the propofol group (40.74%). Both the ciprofol group and propofol group had 100% of the sedation success rate. The anesthesia success rate between the two groups was comparable (P > 0.05). The rate of adverse events was lower (27.52% vs. 45.37%) and patient satisfaction was higher (9.84 ± 0.45 vs. 9.65 ± 0.85) in the ciprofol group than the propofol group. In addition, values of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in propofol group were significantly lower than those in ciprofol group at the time of cervical dilation and consciousness recovery.ConclusionsCiprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.Clinical trial numberNCT06413862.

Comparative Analysis of Hemodynamic Effects of Remimazolam and Propofol Combined with Esketamine in Colonoscopic Procedures in the Elderly.

The debate continues over the differential impact of remimazolam vs propofol on hemodynamic stability. This study aims to elucidate the effects of a combination of remimazolam and esketamine vs propofol and esketamine on hemodynamic parameters in elderly patients undergoing painless colonoscopies. We conducted a randomized controlled trial involving 754 patients, divided equally between two treatment groups. The remimazolam-esketamine group (RE group) received 0.15 mg/kg of remimazolam and 0.3 mg/kg of esketamine. Conversely, the propofol-esketamine group (PE group) was administered 1.5 mg/kg of propofol with 0.3 mg/kg of esketamine. Primary outcomes focused on the incidence of hypotension. Secondary outcomes assessed were other hemodynamic adverse events, intraoperative blood pressure and heart rate fluctuations, usage of vasoactive agents, sedation efficacy, and additional adverse reactions. Hypotension occurred significantly less frequently in the RE group (9.78%, 95% confidence interval[CI]: 6.67-12.87%) compared to the PE group (23.57%, 95% CI: 21.22-30.52%), P<0.001. The RE group also showed lower incidences of sinus tachycardia, sinus bradycardia, and required less support from vasoactive agents (P<0.001). Additionally, the RE group experienced smaller fluctuations in blood pressure and heart rate (P<0.05). Both groups achieved a 100% sedation success rate. Notably, the RE group had a longer induction period but a quicker recovery time (P<0.001), and lower rates of respiratory depression (P=0.006) and injection pain (P<0.001). Remimazolam combined with esketamine offers superior hemodynamic stability and significantly reduces adverse event rates compared to propofol plus esketamine in elderly patients undergoing painless colonoscopies, while maintaining effective sedation.

Efficacy and safety of rectal chloral hydrate for pediatric procedural sedation: A systematic review and meta-analysis.

To evaluate the efficacy and safety of rectal chloral hydrate (CH) in pediatric procedural sedation. Seven electronic databases and 3 clinical trials registry platforms were searched, and the deadline was August 2022. Randomized controlled trials evaluating the efficacy and safety of rectal CH in pediatric procedural sedation were included by 2 reviewers. The extracted outcomes included the success rate of sedation, sedation latency, sedation duration, and adverse events. The Cochrane risk of bias tool was used to assess the risk of bias. The outcomes were analyzed using Review Manager 5.3 software. Forty-four randomized controlled trials with 8007 children were included in the meta-analysis. The success rate of sedation in the rectal CH group was significantly higher than that in the placebo group (risk ratio [RR], 2.60 [95% confidence interval [CI], 1.74-3.89]; P < .01; RR, 1.24 [95% CI, 1.01-1.54]; P = .04), oral CH group (RR, 1.12 [95% CI, 1.09-1.14]; I2 = 36%; P < .001; number needed to treat [NNT] = 10), diazepam group (RR, 1.21 [95% CI, 1.10-1.33]; I2 = 0%; P < .001; NNT = 6), phenobarbital group (RR, 1.24 [95% CI, 1.13-1.35]; I2 = 12%; P < .001; NNT = 6), and ketamine group (RR, 1.39 [95% CI, 1.20-1.60]; I2 = 20%; P < .001; NNT = 5). There was no significant difference in the success rate of sedation between the rectal CH group and the midazolam group (RR, 0.98 [95% CI, 0.86-1.11]; I2 = 51%; P > .05). The sedation latency was significantly shorter in rectal CH group than that in the oral CH group (mean difference [MD], -6.36 [95% CI, -7.04 to -5.68]; I2 = 49%; P < .001) and the phenobarbital group (MD, -7.64 [95% CI, -9.12 to -6.16]; P < .00001). The sedation duration in the rectal CH group was significantly longer than in the oral CH group (MD, 6.43 [95% CI, 4.39-8.47]; I2 = 0%; P < .001). The overall incidence of adverse events was significantly lower with rectal CH than with oral CH (RR, 0.21 [95% CI, 0.16-0.29]; I2 = 45%; P < .001) and ketamine (RR, 0.26 [95% CI, 0.12-0.60]; I2 = 0%; P = .001). There was no significant difference in the overall incidence of adverse events with rectal CH compared with intramuscular midazolam (RR, 0.55 [95% CI, 0.23-1.28]; P = .17) and intranasal midazolam (RR, 3.00 [95% CI, 0.66-13.69]; P = .16). The available evidence suggests that rectal CH cloud be an effective and safe sedative agent for pediatric procedural sedation.

Pediatric Sedation Assessment and Management System (PSAMS) for Pediatric Sedation in China: Development and Implementation Report.

Recently, the growing demand for pediatric sedation services outside the operating room has imposed a heavy burden on pediatric centers in China. There is an urgent need to develop a novel system for improved sedation services. This study aimed to develop and implement a computerized system, the Pediatric Sedation Assessment and Management System (PSAMS), to streamline pediatric sedation services at a major children's hospital in Southwest China. PSAMS was designed to reflect the actual workflow of pediatric sedation. It consists of 3 main components: server-hosted software; client applications on tablets and computers; and specialized devices like gun-type scanners, desktop label printers, and pulse oximeters. With the participation of a multidisciplinary team, PSAMS was developed and refined during its application in the sedation process. This study analyzed data from the first 2 years after the system's deployment. From January 2020 to December 2021, a total of 127,325 sedations were performed on 85,281 patients using the PSAMS database. Besides basic variables imported from Hospital Information Systems (HIS), the PSAMS database currently contains 33 additional variables that capture comprehensive information from presedation assessment to postprocedural recovery. The recorded data from PSAMS indicates a one-time sedation success rate of 97.1% (50,752/52,282) in 2020 and 97.5% (73,184/75,043) in 2021. The observed adverse events rate was 3.5% (95% CI 3.4%-3.7%) in 2020 and 2.8% (95% CI 2.7%-2.9%) in 2021. PSAMS streamlined the entire sedation workflow, reduced the burden of data collection, and laid a foundation for future cooperation of multiple pediatric health care centers.

Comparison of the effects of general anesthesia between remimazolam and propofol in pediatric patients undergoing binocular strabismus day surgery

Objective: To compare the effects of general anesthesia between remimazolam and propofol in pediatric patients undergoing binocular strabismus day surgery. Methods: Prospectively, 60 pediatric patients, American Society of Anesthesiologists (ASA) grade Ⅰ-Ⅱ, scheduled to undergo binocular strabismus daytime surgery in Beijing Tongren Hospital under general anesthesia with laryngeal mask airway from December 2021 to May 2022 were selected. They were randomly divided into Remimazolam group and Propofol group with 30 cases in each group, according to the ratio of 1∶1 by SPSS program. Patients in Remimazolam group were induced by remimazolam, remifentanil and micuronium chloride, and maintained by remimazolam and remifentanil. Patients in Propofol group were induced by propofol, remifentanil and micuronium chloride, and maintained by propofol and remifentanil. Patients in Remimazolam group were given 0.1 mg of flumazenil for antagonism 3 minutes after operation, while children in Propofol group waited for natural awakening. The primary outcome was the time from drug withdrawal to laryngeal mask removal after operation. The secondary outcomes included the time for consciousness loss during induction, intraoperative hemodynamic data [mean arterial pressure (MAP) and heart rate], the success rate of sedation, the awareness rate during operation, and the incidence of adverse events after admission to postanesthesia care unit(PACU). Results: The Remimazolam group included 12 males and 18 females, aged (5.0±1.4) years. There were 14 males and 16 females in the Propofol group, aged (5.3±1.3) years. The time from drug withdrawal to laryngeal mask removal in Remimazolam group was (6.5±1.2) min, which was shorter than that in Propofol group of (10.7±1.9) min (P<0.001). The time for consciousness loss during induction was (38.1±4.8) s in Remimazolam group, which was longer than that in Propofol group of (31.6±4.9) s (P<0.001). The variability of MAP and heart rate of patients during operation in Remimazolam group was lower than that in Propofol group (all P<0.05). There was no significant difference in sedation success rate, intraoperative awareness and adverse reactions in PACU between the two groups (all P>0.05). Conclusion: In pediatric patients with binocular strabismus during daytime surgery, general anesthesia with remimazolam can shorten the time from drug withdrawal to laryngeal mask removal after operation without increasing the incidence of postoperative adverse reactions and can provide more stable hemodynamics.

Randomized controlled trial of remimazolam compared with placebo in Japanese patients undergoing colonoscopy: A phase III, investigator-initiated trial.

We conducted an investigator-initiated clinical trial in which remimazolam was used to achieve sedation in patients undergoing colonoscopy. This multicenter, double-blind, placebo-controlled, phase III investigator-initiated trial included patients who underwent colonoscopy under sedation achieved with remimazolam (initial dose: 3 mg; additional doses: 1 mg) or normal saline (placebo). The primary endpoint was the sedation success rate during colonoscopy, defined as successful sedation (modified observer's alertness/sedation [MOAA/S] score ≤4 prior to colonoscopy), the successful completion of the colonoscopy, and no more than five additional doses of remimazolam per 15 min during the procedure. The sedation success rate was 95.0% (38/40 patients) in the remimazolam group and 0.0% (0/11 patients) in the placebo group (p&lt;0.01). The time from the end of the procedure to awakening was 0.0 (interquartile range: 0.0-0.0) min in both groups. The time from the end of the procedure to ambulation was 5.0 min (interquartile range: 0.0-10.0 min) in the remimazolam group and 0.0 min (interquartile range: 0.0-0.0 min) in the placebo group (p=0.02). No serious adverse events occurred. The use of remimazolam to achieve sedation in Japanese patients undergoing colonoscopy was more effective than the use of a placebo. This study was registered in the Japan Registry of Clinical Trials (registration number: jRCT2031200360).

Comparison of intranasal dexmedetomidine alone and dexmedetomidine-chloral hydrate combination sedation for electroencephalography in children: A large retrospective cohort study and propensity score-matched analysis

AimTo compare the safety and efficacy of intranasal high-dose dexmedetomidine (DEX) versus a combination of intranasal low-dose dexmedetomidine and oral chloral hydrate (DEX-CH) sedation during electroencephalography (EEG) in children. MethodsUnadjusted analysis, 1:1 propensity score matching (PSM), and inverse probability of treatment weighting (IPTW) were used to compare the sedation success rate, adverse effects, onset time, and recovery time of these two sedation methods for 6967 children who underwent EEG. ResultsA total of 6967 children were enrolled in this study, of whom 846 (12.1 %) underwent DEX intranasal sedation while 6121 (87.9 %) received DEX-CH sedation. No significant differences were observed in the sedation success rate with the first dose between the two groups [824 (97.4 %) for DEX vs. 5971 (97.6 %) for DEX-CH; RR 0.99; 95 % CI, 0.98–1.01; P = 0.79]. Similarly, there were no notable disparities in the incidence of adverse events [16 (1.9 %) for DEX vs. 101 (1.7 %) for DEX-CH; RR 1.15; 95 % CI, 0.68–1.93; P = 0.32]. However, intranasal DEX sedation compared with DEX-CH sedation was associated with lower vomiting [0 vs. 95(1.6 %); RR 0.04; 95 % CI, 0.02–0.6; P = 0.02] or more bradycardia [13(1.5 %) vs. 2(0.03 %); RR 47.03; 95 % CI, 10.63–208.04; P < 0.001]. Multivariate analysis using PSM and IPTW analysis yielded similar results. ConclusionBoth methods for EEG had high sedation success rate and low incidence of adverse events. High-dose intranasal DEX was more likely to induce bradycardia and had a shorter recovery time than the DEX-CH sedation, which was more likely to induce vomiting.

Intranasal dexmedetomidine for sedation in ABR testing in children: No pain, big gain!

ObjectivesObtaining perfect immobility or sleep in children undergoing ABR auditory brainstem response) testing can be challenging. We examined the effectiveness and safety of intranasal dexmedetomidine for sedation of children undergoing ABR testing. Material and methodsWe included prospectively all patients aged from 1 to 15 years for whom sedation for ABR testing was required, between July 2018 and November 2021. We administered an initial dose of 2.5 μg/kg intranasal dexmedetomidine with a repeat dose of 1 μg/kg if needed 30 min later. Collected data included success rate of sedation, sedation onset and recovery times and incidence of side effects. ResultsABR testing was undertaken successfully in 57 of the 59 patients, giving a total success rate of 96,6 %. (95 % confidence interval 88.5 %–99.1 %). The median time to onset of sleep was 32 ± 18.3 min. The median duration of sedation recovery time was 48 ± 24.7 min. We recorded the adverse effects. Thirty-one patients experienced bradycardia and 28 patients experienced hypotension, all of which resolved without intervention. ConclusionIntranasal dexmedetomidine is an effective, safe, simple of use and noninvasive method for sedation in children. It could have a major role in auditory brainstem response testing, specially in the case of non-cooperative children. Registration number of the trialNCT03530371.

Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial.

Ciprofol (also known as cipepofol and HSK3486), is a compound similar to propofol in chemical structure and hypnotic effect. Herein we evaluated the efficacy and safety of ciprofol for sedation in outpatient gynecological procedures. This phase III multicenter randomized trial with a non-inferiority design was conducted in nine tertiary hospitals. We enrolled 135 women aged 18-65 years who were scheduled for ambulatory gynecological procedures. Patients were randomly assigned to receive either ciprofol (0.4 mg/kg for induction and 0.2 mg/kg for maintenance) or propofol (2.0 mg/kg for induction and 1.0 mg/kg for maintenance) sedation in a 2:1 ratio. Patients and investigators for data collection and outcome assessment were blinded to study group assignments. The primary outcome was the success rate of sedation, defined as completion of procedure without remedial anesthetics. The non-inferiority margin was set at -8%. Secondary outcomes included time to successful induction, time to full awake, time to meet discharge criteria, and satisfaction with sedation assessed by patients and doctors. We also monitored occurrence of adverse events and injection pain. A total of 135 patients were enrolled; 134 patients (90 patients received ciprofol sedation and 44 patients propofol sedation) were included in final intention-to-treat analysis. The success rates were both 100% in the two groups (rate difference, 0.0%; 95% CI, -4.1 to 8.0%), i.e., ciprofol was non-inferior to propofol. When compared with propofol sedation, patients given ciprofol required more time to reach successful induction (median difference [MD], 2 s; 95% CI, 1 to 7; p < 0.001), and required more time to reach full awake (MD, 2.3 min; 95% CI, 1.4 to 3.1; p < 0.001) and discharge criteria (MD, 2.3 min; 95% CI, 1.5 to 3.2; p < 0.001). Fewer patients in the ciprofol group were dissatisfied with sedation (relative risk, 0.21; 95% CI, 0.06 to 0.77; p = 0.024). Patients given ciprofol sedation had lower incidences of treat-emergent adverse events (34.4% [31/90] vs. 79.5% [35/44]; p < 0.001) and injection pain (6.7% [6/90] vs. 61.4% [27/44]; p < 0.001). Ciprofol for sedation in ambulatory gynecological procedures was non-inferior to propofol, with less adverse events and injection pain. ClinicalTrials.gov, identifier NCT04958746.

Efficacy and safety of remimazolam in bronchoscopic sedation: A meta-analysis.

Remimazolam is a new benzodiazepine used for procedural sedation and general anesthesia. Several studies have used remimazolam for bendable bronchoscopy. To assess the safety and efficacy of remimazolam for sedation in patients undergoing bendable bronchoscopy by performing a meta-analysis of randomized controlled trials (RCTs). We searched the EMBASE, PubMed, Cochrane Library, and Web of Science databases for RCTs on bendable bronchoscopic procedural sedation with remimazolam vs conventional sedatives (CS). Five studies with 1080 cases were included. Remimazolam had the same sedation success rate compared with CS [relative risk (RR): 1.35, 95%CI: 0.60-3.05, P = 0.474, I2 = 99.6%]. However, remimazolam was associated with a lower incidence of hypotension (RR: 0.61; 95%CI: 0.40-0.95, P = 0.027; I2 = 65.1%) and a lower incidence of respiratory depression (RR: 0.50, 95%CI: 0.33-0.77, P = 0.002, I2 = 42.3%). A subgroup analysis showed a higher success rate of sedation with remimazolam than midazolam (RR: 2.45, 95%CI: 1.76-3.42, P < 0.001). Compared with propofol, the incidence of hypotension (RR: 0.45, 95%CI: 0.32-0.64, P < 0.001, I2 = 0.0%), respiratory depression (RR: 0.48, 95%CI: 0.30-0.76, P = 0.002, I2 = 78.4%), hypoxemia (RR: 0.36, 95%CI: 0.15-0.87, P = 0.023), and injection pain (RR: 0.04, 95%CI: 0.01-0.28, P = 0.001) were lower. Remimazolam is safe and effective during bronchoscopy. The sedation success rate was similar to that in the CS group. However, remimazolam has a higher safety profile, with fewer inhibitory effects on respiration and circulation.

Rectal Sedation With Ketamine and Midazolam in the Management of Uncooperative Children During Dental Treatment: A Case Series and Method Description.

Background In pediatric dentistry, sedation aims to eliminate anxiety to facilitate the completion of dental procedures. Sedation in children is a multidimensional field that includes the child, parents/guardians, and the health care team. The rectal route is generally painless, making it suitable for children who are afraid of needles. This route has several advantages over the oral route, including reduced patient cooperation requirements, a faster and more predictable onset, and less physical trauma than the intravenous and intramuscular routes. This case series aimed to evaluate the effectiveness and success rate of rectal sedation with ketamine and midazolam in the management of uncooperative children during dental treatment. Case presentation Ten healthy children with definitely negative behavior were enrolled in this study. Each child was given7 mg/kg of ketamine in combination with midazolam 0.1 mg/kg by the rectal route. The mean onset sedation time was 9.5 minutes, and pulpotomy procedures were done. Behavioral response was monitored throughout treatment using theOhio State University Behavioral RatingScale(OSUBRS), and the depth of sedation was measured using the University of Michigan Sedation Scale (UMSS). The Houpt General Behavior Scale was used to estimate the treatment success rate based on the overall behavior rating. All 10 cases showed good anxiolysis and cooperation following rectal administration, with no side effects observed. Conclusions Rectal administration of ketamine in combination with midazolam may be considered a reliable method in the management of uncooperative children during dental treatment. No adverse effects were observed during or after the sedation procedure.

Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial.

Background: Remimazolam has shown similar or even superior properties to propofol in procedural sedation in adults, but few studies have been conducted in pediatric populations. Thus, we aimed to compare the effect and safety of remimazolam and propofol combined with low dose esketamine for pediatric same-day bidirectional endoscopy (BDE). Methods: Pediatrics <18years scheduled for elective BDE under sedation were included and randomly assigned to remimazolam group (R group) or propofol group (P group). The primary outcome was the success rate of sedation. Secondary outcomes include sedation-related information and adverse events. Mean arterial pressure (MAP), heart rate (HR), and perfusion index (PI) were recorded during sedation. Results: A total of 106 patients were enrolled and analyzed. The success rate of sedation was 100% in both groups. Compared with the P group, the induction time of the R group was significantly prolonged (p < 0.001), and the incidence of injection pain, intraoperative respiratory depression, hypotension and bradycardia was significantly lower (p < 0.001). The changes in MAP, HR and PI were relatively stable in the R group compared with the P group. Additionally, awake time significantly decreased with age by approximately 1.12 index points for each increase in age in the P group (p = 0.002) but not in the R group (p > 0.05). Furthermore, the decline in PI and PI ratio during BDE was related to body movement in the P group. Conclusion: Remimazolam combined with low dose esketamine has a non-inferior sedative effect than propofol for pediatric BDE, with no injection pain, less respiratory depression, more stable hemodynamics. Moreover, early detection of the decline in PI may avoid harmful stimulation under light anesthesia. Clinical trial registration: https://www.clinicaltrials.gov/study/NCT05686863?id=NCT05686863&rank=1, NCT05686863.

Comparison of dexmedetomidine and a dexmedetomidine-esketamine combination for reducing dental anxiety in preschool children undergoing dental treatment under general anesthesia: A randomized controlled trial

BackgroundDental anxiety is a widespread complication occurring in pediatric patients during dental visits and may lead to undesirable complications. Esketamine may be effective in anxiety. ObjectiveThe objective of this study was to investigate the effect of premedication with a dexmedetomidine-esketamine combination compared with dexmedetomidine alone on dental anxiety in preschool children undergoing dental treatment under general anesthesia. MethodsThis is a prospective, double-blinded, randomized controlled trial. A total of 84 patients were scheduled for elective outpatient dental caries treatment under general anesthesia. Patients were randomly premedicated with intranasal dexmedetomidine (group D) or intranasal dexmedetomidine-esketamine (group DS).The primary outcome was the level of dental anxiety assessed by the Modified Child Dental Anxiety Scale (MCDAS) at 2 h after surgery. Secondary outcomes included level of dental anxiety at 1 day and 7 days after surgery, the incidence of dental anxiety at 2 h, 1 day, and 7 days after surgery, sedation onset time, overall success of sedation, acceptance of mask induction, postoperative pain intensity, incidence of emergence agitation in PACU, adverse reactions, HR, and SpO2 before premedication (baseline) and at 10, 20, and 30 min after the end of study drug delivery. ResultsThe dental anxiety in group DS was lower than that in group D at 2 h, 1 day, and 7 days postoperatively (P = 0.04, 0.004, and 0.006, respectively). The incidences of dental anxiety in group DS were lower than those in group D at 2 h (53 % vs 76 %, P = 0.03), 1 day (47 % vs 71 %, P = 0.04), and 7 days (44 % vs 71 %, P = 0.02) after surgery. Group DS had a higher success rate of sedation (P = 0.03) but showed a lower MAS score (P = 0.005) and smoother hemodynamics (P < 0.01) after drug administration than group D. Group DS showed a significantly lower incidence rate of emergence agitation (P = 0.03) and postoperative pain intensity (P = 0.006) than that in group D during the anesthesia recovery time. The occurrence of adverse reactions was similar in both groups (P > 0.05). LimitationsWe did not analyze and correct for the learning effect caused by repeated applications of the MCDAS and MCDAS scores on the 1 day after surgery were obtained by telephone follow-up. ConclusionsCompared to premedication with dexmedetomidine alone, premedication with intranasal dexmedetomidine combined with esketamine could significantly improve dental anxiety in preschool children undergoing dental treatment under general anesthesia.

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

BackgroundDental 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.MethodsThirty-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.ResultsThe 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.ConclusionsContinuous 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.Trial registrationThe study was registered in the Japan Registry of Clinical Trials (No. jRCTs061220052) on 30/08/2022.

The effect of age on outpatient pediatric procedural sedation with intranasal dexmedetomidine and oral midazolam

Procedural sedation for diagnostic examination is a common practice in children. The study aims to analyze the sedative effect and safety of intranasal dexmedetomidine combined with oral midazolam in outpatient pediatric procedural sedation across different age groups and to assess the incidence of sedation failure. From February 2021 to September 2021, children who underwent procedural sedation were retrospectively enrolled. The children were divided into 4 groups based on age: the infant group (0 to 1 year old), toddler group (1 to 3 years old), preschool group (3 to 6 years old), and school-age group (6 to 12 years old). Two-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam were used for sedation. The sedation success rate after rescue, sedation success rate, onset time of sedation, and the sedation time were recorded. The incidence of adverse events and the risk factors for sedation failure were also analyzed. A total of 4758 patients were identified. After exclusion, 3149 patients were ultimately enrolled. The combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam resulted in a total success rate of 99.7% and a sedation success rate of 91.4%. The sedation success rate varied among the four groups: 90.2% in the infant group, 93.1% in the toddler group, 92.7% in the preschool group, and 78.4% in the school-age group. The sedation success rate was significantly lower in the school-age group compared to the other three groups (P < 0.001). The onset time of sedation was shorter in infant (22 min, IQR: 18–28 min, P < 0.001) and longer in the school-age group (30 min, IQR: 25–35 min, P < 0.05). Additionally, the infants had a longer sedation time (110 min, IQR: 90–135 min, P < 0.001) and a higher rate of delayed recovery (27.5%, all P < 0.001). The incidence of adverse events was low (4.70%), which bradycardia (2.03%) being the most common. Age (0–1 year and > 6 years), weight, ASA class II, and history of failed sedation were identified as risk factors of sedation failure. Conclusion: Intranasal administration of 2-mcg/kg dexmedetomidine combined with oral administration of 0.5-mg/kg midazolam was found to be efficient and safety for pediatric procedural sedation. Different age groups of children exhibited distinct sedation characteristics, and age was identified as a risk factor affecting the efficacy of sedation.What is Known:• Procedural sedation for diagnostic examination is a common practice in children.• The combination of dexmedetomidine with midazolam can improve sedative effects.What is New:• The success rate of sedation using a combination of 2-mcg/kg intranasal dexmedetomidine and 0.5-mg/kg oral midazolam was significantly lower in school-age children as compared to infants, toddlers, and preschoolers.• The onset time of sedation increased with age, and the sedation time was found to be longer in infant patients.

Remimazolam for sedation: A protocol for a systematic review with meta-analysis, trial sequential analysis, and GRADE approach.

Procedural sedation aims to facilitate a successful diagnostic or therapeutic procedure. The pharmacokinetic properties and pharmacodynamic effects need to be taken into consideration when choosing the ideal sedative. Midazolam and propofol are frequently employed. However, they are associated with respiratory depression with increasing dosage. Also, midazolam has a potentially unpredictable pharmacodynamic response and propofol may cause hypotension and injection site pain. Remimazolam may provide a superior alternative due to its rapid pharmacodynamic profile and insignificant circulatory effects. This protocol employs the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The review aims to assess the beneficial and harmful clinical effects of remimazolam versus placebo or other sedatives in adult patients requiring sedation in relation to a diagnostic or therapeutic procedure, or due to other circumstances. Three primary outcomes are identified: Sedation success rate, respiratory complications, and hemodynamic complications. Six secondary outcomes are identified: among these are quality of recovery and serious adverse events. All randomized trials are included. The search strategy includes six major biomedical databases. Literature screening and data extraction will be performed independently by two authors. Risk of systemic error will be assessed with Risk of Bias 2 Tool. Risk of random error will be assessed with trial sequential analysis. Heterogeneity will be evaluated by appropriate statistical tests. The certainty of the evidence will be judged using Grading of Recommendations Assessment, Development, and Evaluation. Meta-analysis will be carried out with Rstudio. A "Summary of Findings" table will be presented with our primary and secondary outcome results. The systematic review with up-to-date methodology outlined in this protocol investigates the clinical effects of remimazolam in relation to procedural sedation. The results may guide clinicians in the clinical use of remimazolam.

Remimazolam versus propofol for procedural sedation: a meta-analysis of randomized controlled trials.

To improve patient tolerability and satisfaction as well as minimize complications, procedural sedation has been widely used. Propofol is the most widely used agent for induction of anesthesia and sedation by anesthesiologists. With a different mechanism compared to propofol, remimazolam is a new short-acting GABA-A receptor agonist. It is an ester-based benzodiazepine. This meta-analysis aims to clarify the efficacy and safety of remimazolam versus propofol for procedure sedation. Electronic databases were searched for randomized controlled trials (RCTs) comparing efficacy or safety of remimazolam versus propofol. Meta-analysis were conducted using RStudio with "metafor" package with random-effects model. A total of twelve RCTs were included in the meta-analysis. The pooled results demonstrated that patients with remimazolam for procedural sedation had lower risk of bradycardia (OR 0.28, 95% CI [0.14-0.57]), hypotension (OR 0.26, 95% CI [0.22-0.32]), and respiratory depression (OR 0.22, 95% CI [0.14-0.36]). There was no difference in the risk of developing postoperative nausea and vomiting (PONV) (OR 0.65, 95% CI [0.15-2.79]) and dizziness (OR 0.93, 95% CI [0.53-1.61]) between the remimazolam and propofol groups. Using remimazolam for procedural sedation is significantly associated with less injection pain compared to propofol (OR 0.06, 95% CI [0.03-0.13]). Regarding the sedation efficacy, there was no difference in sedation success rate or time to loss of consciousness, recover and discharge between the remimazolam and the propofol groups. Based on our meta-analysis, patients receiving procedural sedation with remimazolam had lower risk of bradycardia, hypotension, respiratory depression and injection pain compared with propofol. On the other hand, there was no difference in sedation success rate, risk of PONV, dizziness, time to LOC, recovery and discharge between these two sedatives. CRD42022362950.

Comparison of Remimazolam and Propofol for Drug-Induced Sleep Endoscopy: A Randomized Clinical Trial.

To compare the efficacy and safety of remimazolam with those of propofol for drug-induced sleep endoscopy (DISE) in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS). A prospective, single-center, randomized clinical trial. Xiangya Hospital of Central South University. Patients with OSAHS receiving DISE were randomly assigned to either the remimazolam or propofol group. The primary outcome was the incidence of hypoxemia (pulse oxygen saturation [SpO2 ] < 90%) during DISE. The secondary outcomes were the incidence of severe hypoxemia (SpO2 < 80%), the minimal value of SpO2 , sedation success rate (completion of DISE according to the medication regimen), and incidence of events of interest (including injection pain, bradycardia, and decreased respiratory rate). Sixty-four patients were included in this study. The incidence of hypoxemia was significantly lower in the remimazolam than in the propofol group (25.00% vs62.50%, respectively; relative risk, 0.40; 95% confidence interval [CI], 0.20-0.74; p < .01). There was no significant difference in the sedation success rate between the remimazolam and propofol groups (96.88% vs81.25%, respectively; relative risk, 1.19; 95% CI, 1.01-1.50; p = .10). The incidence of at least 1 event of interest was lower in the remimazolam than in the propofol group (43.75% vs96.88%, respectively; relative risk, 0.45; 95% CI, 0.29-0.63; p < .01). Remimazolam can present satisfactory sedative efficacy in DISE, with a lower incidence of hypoxemia and a higher safety profile than propofol.