Adult patients with cognitive or neurodevelopmental disabilities (e.g., intellectual disability, autism spectrum disorder, cerebral palsy) who require dental procedures that cannot be performed under conventional conditions, thus necessitating intravenous sedation for safe and effective care. Mental and Behavioural Disorders
Conditions
Interventions
All participants received intravenous procedural sedation with remimazolam besylate administered by an anesthesiologist during outpatient dental treatment.
Sedation was induced with a starting dose of
Sponsors
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients aged 18 years or older with a diagnosis of cognitive or neurodevelopmental disability (including intellectual disability, autism spectrum disorder, or cerebral palsy) who require outpatient dental treatment under intravenous sedation 2. Classified as ASA physical status II or III 3. Had a stable medical condition 4. Deemed suitable for procedural sedation according to the institutional protocol 5. Written informed consent obtained from the caregiver or legal guardian before inclusion
Exclusion criteria
Exclusion criteria: 1. Severe systemic diseases corresponding to ASA physical status IV or higher 2. Unstable cardiovascular or respiratory conditions 3. Known hypersensitivity to benzodiazepines or remimazolam components, or a history of adverse reactions to sedative agents. 4. Significant hepatic or renal impairment 5. Active respiratory infection 6. Pregnancy or breastfeeding 7. Those receiving medications known to interfere with benzodiazepine metabolism 8. Whose caregivers or legal guardians were unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedural success rate is measured using data extracted from patient medical records at the end of the dental procedure, defined as the ability to complete the dental treatment under remimazolam sedation alone with adequate clinical sedation, maintenance of spontaneous ventilation, and no adverse events requiring intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Onset time of sedation: Onset time of sedation is measured in minutes using the Ramsay Sedation Scale (target score = 4) assessed intraoperatively from the initial administration of remimazolam. 2. Recovery time: Recovery time is measured in minutes from the end of remimazolam administration to the achievement of full clinical recovery, assessed post-procedure through direct clinical observation of the patient’s return to baseline responsiveness, orientation, and spontaneous motor activity. 3. Hemodynamic and respiratory stability: Hemodynamic and respiratory stability are measured using continuous anesthetic monitoring of blood pressure, heart rate, SpO2, and respiratory rate recorded throughout the intraoperative period. 4. Adverse events: Adverse events are measured using clinical observation and medical record documentation intraoperatively and post-procedure, and include the incidence and type of sedation-related complications (e.g., hypoxemia, hypotension, nausea, vomiting). 5. Postoperative discharge readiness: Postoperative discharge readiness is measured using both the Post-Anesthetic Discharge Scoring System (PADSS) and the Modified Aldrete Score (MAS), with readiness defined as PADSS = 8 and MAS = 9, assessed immediately before discharge from the dental unit. | — |
Countries
Italy
Contacts
Public ContactGiovanni Battista Grossi
Outcome results
None listed