Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

Tongji Hospital

Status: Completed

Conditions: Fiberoptic Bronchoscopy

Treatments: Drug: Dexmedetomidine injection; Drug: Remimazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT06755996

DEXS

Details and patient eligibility

About

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

Full 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

Enrollment: 150 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

DR1 group

Active Comparator group

Description:

Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group

Treatment:

Drug: Remimazolam

Drug: Dexmedetomidine injection

DR2 group

Experimental group

Description:

Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group

Treatment:

Drug: Remimazolam