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Completed

NCT Number: NCT06755996

Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

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

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji hospital

Wuhan, Hubei, 430030, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine Injection

Drug

Dexmedetomidine injection 3μg/kg

Other names: dex inj

Remimazolam

Drug

remimazolam 0.5mg / kg

Other names: remi

Primary outcomes

  1. Sedation success rate

    Time frame: 1day

    MOSS / A score =4-point time

Secondary outcomes

  1. recoving time

    Time frame: 1day

    Wake up time

  2. Drug dosage

    Time frame: 1day

    dosage of dexmeditomidine and remimazolam

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 1, 2025
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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