Efficacy of Remimazolam besylate for intravenous sedation in dental procedures for patients with cognitive disabilities: a prospective single-arm observational study.
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.