The sedation success rate of remimazolam is non-inferior to that of propofol, and patients who receive remimazolam for hysteroscopy exhibit lower incidences of hypotension, hypoxemia, and injection pain than patients who receive propofol.
Abstract
Procedural sedation is widely used to improve patient tolerability and satisfaction and minimize complications. Propofol is the most commonly used agent in procedural sedation, but its use is associated with a number of adverse effects. Remimazolam, which has a different mechanism of action compared to propofol, is a short-acting GABA-A receptor agonist. It is being increasingly used in procedural sedation. This meta-analysis aims to clarify the efficacy and safety of remimazolam versus propofol for procedural sedation in hysteroscopic surgery. We systematically searched studies published in PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials from the inception of the databases to February 28, 2025, for randomized controlled trials (RCTs) comparing the effect of remimazolam and propofol in procedural sedation for hysteroscopic surgery. Seven RCTs (n = 664 patients) met our inclusion criteria. The pooled results showed that remimazolam significantly reduced the risk of injection pain, hypoxemia, and hypotension (all P < 0.0001) in hysteroscopic surgery, with a sedation success rate comparable to that of propofol (P = 0.05). There were no significant differences in the risks of postoperative dizziness, postoperative nausea and vomiting (PONV), or bradycardia. Findings from sensitivity analyses suggested a potentially higher risk of body movement with remimazolam. We conclude that the sedation success rate of remimazolam is non-inferior to that of propofol, and patients who receive remimazolam for hysteroscopy exhibit lower incidences of hypotension, hypoxemia, and injection pain than patients who receive propofol. Therefore, remimazolam represents a safer alternative to propofol for procedural sedation in hysteroscopic procedures, with a distinct safety profile. Nevertheless, its risk-benefit profile should be carefully evaluated in clinical practice.
BACKGROUND
Remimazolam is a novel ultra-short-acting intravenous benzodiazepine, while sevoflurane is a widely used inhalational anaesthetic for general anaesthesia (GA). Both agents are associated with risks of haemodynamic instability and postoperative nausea and vomiting (PONV), which can affect patient safety and recovery.
OBJECTIVE
To compare the efficacy and safety of remimazolam versus sevoflurane in terms of intraoperative haemodynamic stability during the maintenance phase of GA or deep sedation, and the incidence of PONV.
DESIGN
Systematic review of randomised controlled trials (RCTs) and meta-analysis, with trial sequential analysis (TSA).
DATA SOURCES
PubMed/MEDLINE, Embase, Cochrane CENTRAL, Web of Science and Scopus were systematically searched from inception to April 2025.
ELIGIBILITY CRITERIA
RCTs comparing intraoperative use of remimazolam and sevoflurane with reported intraoperative or postoperative outcomes. Conference abstracts were excluded.
RESULTS
Twelve RCTs (n = 739 patients; mean age 61.6 years; 36.8% laparoscopic procedures) were included. Remimazolam significantly reduced the risk of intraoperative hypotension (as a binary event) compared with sevoflurane [risk ratio (RR) 0.38, 95% confidence interval (CI) 0.25 to 0.57; P < 0.001]. Mean arterial pressure (MAP) was higher with remimazolam at 30 min after start of surgery (mean difference 6.05 mmHg, P < 0.03). Heart rate (HR) was consistently higher with remimazolam at 30 min (P = 0.04), at the end of surgery (P < 0.01) and in the postanaesthesia care unit (P < 0.01). Analyses suggested a reduction in PONV incidence up to 24 h with remimazolam [RR 0.65 (95% CI, 0.47 to 0.90); P = 0.01] and 72 h [RR 0.66 (95% CI, 0.50 to 0.89)]. TSA just confirmed favouring remimazolam in reducing intraoperative hypotension.
CONCLUSIONS
Remimazolam was associated with a lower incidence of intraoperative hypotension compared with sevoflurane, while differences in MAP and HR were limited to specific time points. Sensitivity analyses suggested a potential reduction in PONV; however, these findings were not statistically significant in the primary analysis and should be interpreted with caution.
Unknown authors· European Journal of Anaesthe...· 0 citations
Despite the growing interest in remifentanil for endoscopic procedures, available data are conflicting. Objective. To evaluate efficacy and safety of remifentanil and fentanyl for analgesia in adults undergoing endoscopic procedures. Material and methods. Nine biomedical databases were screened regarding randomized controlled trials (RCTs) involving remifentanil or fentanyl as components of analgesia for endoscopic procedures under spontaneous breathing in adults. Primary endpoints included procedural measures (time to induction, recovery and complete recovery, achievement of discharge criteria), incidence of intraoperative respiratory depression and postoperative pain. The review was conducted in accordance with the PRISMA 2020 guidelines. Results. Meta-analysis included 16 RCTs (1.242 patients). Remifentanil provided faster induction (MD –1.47 min, 95% CI –2.27 to –0.68, p=0.0003) and awakening (MD –2.98 min, 95% CI –4.25 to –1.72, p<0.00001) compared to fentanyl. Remifentanil provided earlier complete recovery (MD –5.64 min, 95% CI –7.67 to –3.61, p<0.00001) and complete recovery for discharge (MD –22.24 min, 95% CI –26.91 to –17.57, p<0.00001). Remifentanil was associated with a trend towards higher risk of respiratory depression compared to fentanyl, but the difference was insignificant (RR=1.25; 95% CI 0.89 to 1.75; p=0.19). Both opioids had equivalent profiles in terms of blood pressure control, bradycardia risk, and postoperative pain. Conclusion. Remifentanil significantly reduces time to induction, recovery and complete recovery, as well as achievement of discharge criteria in endoscopic procedures in adults. However, these results are preliminary due to low certainty of evidence (GRADE ). When using remifentanil, strict monitoring of gas exchange and readiness for mechanical ventilation are necessary. Further randomized controlled trials are needed to determine optimal dose of remifentanil, especially in high-risk patients.
N. Barkovskaya, E. Shifman, D. Protsenko et al.· Russian Journal of Anesthesi...· 0 citations
This study aimed to explore the efficacy and safety of remimazolam vs. propofol for sedation during video laryngoscopy in cervical spondylosis patients with suspected difficult laryngoscopy.
In this single-center, prospective, randomized controlled study, 85 patients with Modified Mallampati class III or IV and limited cervical spine mobility were recruited and randomly assigned (1:1 ratio) to receive either remimazolam or propofol sedation. The primary outcome was the incidence of hypoxemia (SpO₂< 90% for >10 s). Secondary outcomes included sedation efficacy and side effects.
The incidence of hypoxemia was significantly lower in the remimazolam group (13.6%) than in the propofol group (39.0%;
P
= 0.008), with an absolute risk difference of 25.4% (95% confidence interval 0.073–0.434). The propofol group required more additional airway interventions (
P
= 0.007). After adjusting for age, gender, and body mass index, propofol was associated with higher odds of hypoxemia (adjusted odds ratio = 4.602; 95% confidence interval 1.330–15.922;
P
= 0.016) and more advanced airway interventions (adjusted odds ratio = 4.598; 95% confidence interval 1.395–15.152;
P
= 0.012). Injection pain occurred in 31.7% of propofol patients but was absent in the remimazolam group (
P
< 0.001).
Remimazolam provides effective and safe sedation for video laryngoscopy in cervical spondylosis patients with suspected difficult laryngoscopy, significantly reducing the incidence of hypoxemia and the need for airway interventions compared to propofol.
Trial registration:
This protocol was approved by Peking University Third Hospital Medical Science Research Ethics Committee (IRB00006761–M2024420, June 2024) and was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2400086137, June 2024).
Bin Zhang, Jiao Li, Mingya Wang et al.· European Journal of Medical...· 0 citations
Background: Procedural sedation in children remains a complex clinical challenge. Midazolam has served as the conventional standard, yet intranasal dexmedetomidine has emerged as an attractive alternative offering potential advantages regarding respiratory safety alongside improved behavioral recovery.
Objectives: To systematically review and meta-analyze the evidence from randomized controlled trials comparing the efficacy and safety of intranasal dexmedetomidine versus midazolam for procedural sedation in children aged 0-18 years.
Methods: Adhering strictly to PRISMA guidelines, a systematic search of major databases identified relevant randomized controlled trials comparing these agents. Two independent reviewers selected eligible studies, extracted data, and conducted formal risk of bias assessments. Meta-analytic data pooling utilized random-effects models.
Results: Eight trials encompassing 716 children were included. Primary endpoints proved not statistically significant: sedation onset trended faster towards midazolam (SMD=1.22; I²=96.7%), whereas satisfactory sedation trended favorably toward dexmedetomidine (RR=1.23; I²=78.4%). Importantly, dexmedetomidine significantly reduced postoperative anxiety (MD=-0.81; I²=0%), emergence delirium (RR=0.31; I²=0%), and emergence agitation (RR=0.36; I²=0%) without prolonging awakening time (MD=0.30; I²=0%). Narrative synthesis indicated fewer respiratory adverse events with dexmedetomidine.
Conclusion: Primary efficacy outcomes demonstrated statistically insignificant differences, although robust evidence indicates intranasal dexmedetomidine is highly superior for pediatric behavioral recovery. Dexmedetomidine effectively minimizes emergence delirium, agitation, and anxiety without inappropriately prolonging baseline awakening times, while demonstrating a safer perioperative respiratory profile. Midazolam maintains a practical edge strictly for rapid onset. Current evidence remains heavily limited by small sample sizes and substantial clinical heterogeneity. Well-powered multicenter trials utilizing standardized outcomes are urgently needed to fully resolve clinical dosing protocols today.
Ahmad M.Alridahie, Saleh K.Almasoud, Ammar K.Alhajjaj et al.· Annals of Middle Eastern Med...· 0 citations
