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Intramuscular injection of dexmedetomidine and midazolam for sedation in pediatric brain magnetic resonance imaging, a clinical study.

Intramuscular injection of dexmedetomidine and midazolam for sedation in pediatric brain magnetic resonance imaging, a clinical study.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072302
Enrollment
Unknown
Registered
2023-06-09
Start date
2023-06-10
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Children with autism undergoing magnetic resonance imaging examination

Interventions

Research group:Before the magnetic resonance examination, intramuscular injection was administered with 3ug/kg of dexmedetomidine, 0.2mg/kg of midazolam, and 0.02mg/kg of atropine.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of autism spectrum disorder in DSM-5; 2) Age 2-14 years old, regardless of gender; 3) Proposed MRI examination; 4) ASA score level I-II; 5) Clearly understand, voluntarily participate in the study, and have their legal guardian sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Individuals with contraindications to general anesthesia; 2) Patients who have used sedatives and analgesics within 24 hours or anesthetics within 5 days, and those who have taken benzodiazepines or opioid analgesics within the past 6 months; 3) Suffering from brain organic disease, trauma and other serious nervous system disease; 4) Children with fragile X syndrome and Rett syndrome; 5) Allergies or contraindications to chloral hydrate, benzodiazepines, dexmedetomidine, atropine, flumazenib, and their drug components; 6) Patients diagnosed with difficulty in respiratory management 7) Appearing symptoms of upper respiratory tract colds; 8) Children who do not fast or drink according to the doctor's instructions; 9) Participated in drug clinical trials as a subject within the past 3 months; 10) Researchers believe that patients should not participate in this trial.

Design outcomes

Primary

MeasureTime frame
Success rate of sedation with the first dose of anesthesia;

Secondary

MeasureTime frame
Perianesthesia hemodynamic indicators;Sedation onset time;Calm Awakening Time;After the first dose of medication fails to calm down, the dosage and usage of additional medication should be supplemented;

Countries

China

Contacts

Public ContactTao Meng

Qilu Hospital of Shandong University

mengtao@sdu.edu.cn+86 156 1561 8039

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026