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Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

Combination of Dexmedetomidine Nasal Spray and Remimazolam for the Treatment of Pediatric Bronchoscopy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06755996
Enrollment
150
Registered
2025-01-01
Start date
2025-01-07
Completion date
2025-08-31
Last updated
2026-01-27

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

Conditions

Fiberoptic Bronchoscopy

Brief summary

To observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Detailed description

Dexmedetorimidine nasal spray is a new dosage form, which is simple and easy to achieve sedative and anti-anxiety effects by nasal spray mucosa. In the dose range from 50 to 100 μ g, the sedation effect increased dose-dependent, with\> 2 μ g / kg administered, and the child could be successfully separated within 45min.Our study is to observe the sedative effect of using dexmedetomidine nasal spray combined with remimazolam for pediatric bronchoscopy diagnosis and treatment, provide a safer and more comfortable anesthesia plan for pediatric bronchoscopy diagnosis and treatment

Interventions

DRUGDexmedetomidine injection

Dexmedetomidine injection 3μg/kg

DRUGRemimazolam

remimazolam 0.5mg / kg

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

* Age 2-6 years old (24\~72 months); * ASA I-II; * sign the informed consent.

Exclusion criteria

* Severe rhinitis, nasal deformity; * abnormal liver and kidney function; * severe dehydration, severe malnutrition, hypoproteinemia or anaemia Hb \<10 g/dl; * children with neurological disease; * history of allergy to the study drug; * recent participation in other clinical studies.

Design outcomes

Primary

MeasureTime frameDescription
Sedation success rate1dayMOSS / A score =4-point time

Secondary

MeasureTime frameDescription
recoving time1dayWake up time
Drug dosage1daydosage of dexmeditomidine and remimazolam

Countries

China

Contacts

STUDY_CHAIRpu zhou, Dr.

Tongji Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026