Tokyo, May 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061617) titled 'Research on Nasal Midazolam Given Before Anesthesia for People with Intellectual Disabilities' on May 20.

Study Type: Observational

Primary Sponsor: Institute - Hiroshima University Hospital

Condition: Condition - Patients with Intellectual Disabilities Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the efficacy and clinical usefulness of intranasal midazolam as a premedication for patients with intellectual disabilities undergoing general anesthesia. While conventional oral administration requires patient cooperation, the intranasal route allows for reliable delivery even in uncooperative cases. This study investigates the sedative effects and appropriate administration methods for this patient population, including adolescents and adults. Ultimately, we aim to contribute to a safer, less stressful anesthesia induction process that minimizes both physical and psychological burdens. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 15 years-old = Gender - Male and Female Key inclusion criteria - This study includes patients aged 15 to 65 with intellectual disabilities who underwent general anesthesia at our university's Department of Dental Anesthesiology. Specifically, the study includes patients who received intranasal premedication with midazolam. Since patients with intellectual disabilities may find it difficult to express refusal themselves, their guardians or legal representatives are also included in the study. Key exclusion criteria - Concomitant Sedatives: Patients who received other temporary pre-anesthetic sedative medications (oral, intravenous, or rectal) prior to the intranasal midazolam administration, which would confound the assessment of its specific sedative efficacy (scheduled daily medications were allowed).

Incomplete Clinical Data: Patients with substantial missing information in their medical or anesthetic records regarding primary outcomes, such as the exact midazolam dose, administration route, post-administration sedation scores (e.g., RASS), success of anesthesia induction, or adverse events.

Refusal of Data Consent: Cases where the patient, parents, or legal guardians opted out and refused the use of their clinical data for this study. Target Size - 15

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 18 Day Date of IRB - 2026 Year 02 Month 12 Day Anticipated trial start date - 2026 Year 05 Month 20 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070495

Disclaimer: Curated by HT Syndication.