OBJECTIVES
To assess the efficacy and safety of intravenous remimazolam besylate for sedation during dental procedures in patients with cognitive disabilities, a group frequently managed under general anesthesia due to poor cooperation and increased perioperative risks.
MATERIALS AND METHODS
In this single-center prospective single-arm observational study, 43 adult patients with cognitive or motor disabilities (ASA II-III) received outpatient dental care under intravenous remimazolam. Sedation was titrated to moderate levels according to EMA and IACSD guidelines. Outcomes included procedural success, Ramsay Sedation Scale, Post-Anesthetic Discharge Scoring System (PADSS), Modified Aldrete Score (MAS), vital signs, drug dosage, recovery, adverse events, and caregiver feedback.
RESULTS
All treatments were successfully completed without anesthesiologist intervention or flumazenil reversal. Mean onset of sedation was 3.8 ± 2.3 min, recovery time 47 ± 20.4 min, and time to discharge 72.5 ± 22.5 min. The mean total remimazolam dose was 14 ± 5.9 mg. Most patients reached Ramsay 4, while 9.7% remained ≤ 3. Vital parameters remained stable with no episodes of hypoxemia or airway compromise. At discharge, PADSS averaged 8.9 ± 1.0 and MAS 9.4 ± 0.6, confirming recovery despite motor or neurological limitations affecting PADSS scoring. Caregiver interviews indicated that 42% of patients slept during the day, 85% slept normally at night, 68% appeared calmer, and only 7% experienced minor adverse effects such as nausea or brief agitation.
CONCLUSIONS
Remimazolam provided safe and effective intravenous sedation with rapid onset and reliable recovery. Combining PADSS with MAS improved discharge assessment in this patient population.
CLINICAL RELEVANCE
Remimazolam deserves further investigation as a potential practical alternative to general anesthesia for dental procedures in patients with cognitive disabilities, with the potential to enable safe care, procedural success, and favorable recovery profiles.
TRIAL REGISTRATION
International Standard Randomised Controlled Trial Number (ISRCTN) registry, ISRCTN39322806. Retrospectively registered on 10 November 2025.
G. Grossi, G. Menozzi, Matteo Pellegrini et al.· BMC Oral Health· 0 citations
Highlights What are the main findings? Outpatient conscious sedation with titrated nitrous oxide/oxygen, alone or combined with midazolam, enabled the successful completion of all planned complex dental and minor oral surgical procedures in selected uncooperative pediatric and special needs patients. No procedure required conversion to deep intravenous sedation or general anesthesia, and no major adverse events or airway emergencies were observed. What are the implications of the main findings? Appropriate patient selection, behavioral management and clinician expertise may allow complex pediatric dental procedures to be completed under conscious sedation in selected patients. Dedicated outpatient Conscious Sedation Units may provide an additional treatment pathway for selected pediatric patients; however, their effect on access to care, hospital-resource utilization, and costs requires dedicated comparative evaluation. Abstract Aim: This two-center retrospective observational study evaluated whether outpatient conscious sedation protocols based on titrated nitrous oxide/oxygen, midazolam, or their combination enabled complex dental and minor oral surgical procedures to be completed in uncooperative pediatric and special needs patients, without escalation to deep intravenous sedation or general anesthesia. Materials and Methods: Forty pediatric and special needs patients treated at the Conscious Sedation Units of Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico (Milan, Italy) and Policlinico of Bari (Bari, Italy) were included. Overall, 60 complex dental or minor oral surgical procedures were performed. Procedures were classified according to the sedation protocol administered: Protocol A, nitrous oxide/oxygen inhalation sedation alone; Protocol B, midazolam alone; and Protocol C, combined midazolam and nitrous oxide/oxygen sedation. Vital signs were monitored before, during, and after treatment. The primary outcome was successful procedural completion, defined as completion of the planned procedure without premature termination, escalation to deep intravenous sedation or general anesthesia, or the need for unplanned airway or emergency medical intervention. Results: Forty patients underwent 60 procedures. The mean age was 8.7 ± 2.3 years (range, 4–14 years). Protocol A was used in 24 procedures (40%), Protocol B in 6 procedures (10%), and Protocol C in 30 procedures (50%). All procedures were completed successfully, with no conversion to general anesthesia, no airway crises, and no medical emergencies. Transient elevations in heart rate and blood pressure during local anesthesia occurred in 11/60 procedures (18.3%), and mild self-limiting nausea or fatigue occurred in 5/60 procedures (8.3%). Conclusions: The evaluated protocols were associated with successful procedural completion and few recorded adverse events in this selected cohort. Combined behavioral and pharmacological management was associated with completion of the planned procedures without conversion to deep intravenous sedation or general anesthesia. Comparative studies are required to determine whether these protocols reduce general-anesthesia utilization.
Lucia Giannini, N. Cenzato, G. Menozzi et al.· Children· 0 citations