UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061617 |
|---|---|
| Receipt number | R000070495 |
| Scientific Title | Evaluation of Intranasal Midazolam as Premedication for Patients with Intellectual Disabilities |
| Date of disclosure of the study information | 2026/05/20 |
| Last modified on | 2026/05/18 17:44:49 |
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Basic information
Public title
Research on Nasal Midazolam Given Before Anesthesia for People with Intellectual Disabilities
Acronym
Research on Nasal Midazolam Given Before Anesthesia for People with Intellectual Disabilities
Scientific Title
Evaluation of Intranasal Midazolam as Premedication for Patients with Intellectual Disabilities
Scientific Title:Acronym
Evaluation of Intranasal Midazolam as Premedication for Patients with Intellectual Disabilities
Region
| Japan |
Condition
Condition
Patients with Intellectual Disabilities
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Depth of sedation upon entering the operating room
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kana |
| Middle name | |
| Last name | Oue |
Organization
Hiroshima University Hospital
Division name
Dental Anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima 734-8553 Japan
TEL
0822575733
owen-0428@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Oue |
Organization
Hiroshima University Hospital
Division name
Dental Anesthesiology
Zip code
7348551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima 734-8553 Japan
TEL
0822575733
Homepage URL
owen-0428@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima 734-8553 Japan
Tel
0822575733
owen-0428@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study.
This study targets patients aged 15 to 65 years with intellectual disabilities (ID) who are scheduled to undergo dental procedures under general anesthesia and receive intranasal midazolam as a premedication. Detailed information regarding the study protocol will be disclosed on the Hiroshima University website, and an opt-out approach will be implemented to provide patients and their legal guardians the opportunity to refuse participation.
The following demographic and clinical variables will be extracted from the medical and anesthetic records: age, sex, type and severity of disability, baseline level of medical cooperation, underlying medical conditions, and details of the dental treatment. Furthermore, anesthesia-related data will be recorded, including the specific administration method, dosage of midazolam, serial changes in vital signs, time to onset of sedation, patient tolerance to monitoring equipment during anesthesia induction, the method of anesthesia induction, and the level of sedation assessed using the Richmond Agitation-Sedation Scale (RASS).
The collected data will be compiled and analyzed to evaluate the clinical efficacy and usefulness of intranasal midazolam as a pre-anesthetic medication in this patient population.
Management information
Registered date
| 2026 | Year | 05 | Month | 18 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070495
