Research on Nasal Midazolam Given Before Anesthesia for People with Intellectual Disabilities

Evaluation of Intranasal Midazolam as Premedication for Patients with Intellectual Disabilities - Evaluation of Intranasal Midazolam as Premedication for Patients with Intellectual Disabilities

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061617

Enrollment

Registered

2026-05-20

Start date

2026-05-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Intellectual Disabilities

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Depth of sedation upon entering the operating room	—

Secondary

Measure	Time frame
Midazolam dosage, patient cooperation during premedication, time to onset of effect, depth of sedation, vital signs during sedation, vital signs upon admission, tolerance to monitoring, mask placement, and IV line placement during induction of anesthesia, method of induction, duration of anesthesia, duration of surgery, duration of recovery from anesthesia, postoperative course, postoperative patient condition, adverse events	—

Measure

Time frame

Midazolam dosage, patient cooperation during premedication, time to onset of effect, depth of sedation, vital signs during sedation, vital signs upon admission, tolerance to monitoring, mask placement, and IV line placement during induction of anesthesia, method of induction, duration of anesthesia, duration of surgery, duration of recovery from anesthesia, postoperative course, postoperative patient condition, adverse events

—

Countries

Japan

Contacts

Public ContactKana Oue

Hiroshima University Hospital Dental Anesthesiology

owen-0428@hiroshima-u.ac.jp0822575733

Outcome results