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.