Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

Not Applicable

Recruiting

• Conditions: Fiberoptic Bronchoscopy
• Interventions: Drug: Dexmedetomidine injection; Drug: Remimazolam

• Registration Number: NCT06755996
• Lead Sponsor: Tongji Hospital

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

Study Timeline

• Study First Submitted: 2024-12-25
• Study First Submitted QC: 2024-12-25
• Study Start: 2025-01-01
• Study First Posted: 2025-01-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DR1 group	Remimazolam	Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group
DR2 group	Remimazolam	Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group
DR1 group	Dexmedetomidine injection	Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group

Primary Outcome Measures

Name	Time	Method
Sedation success rate	1day	MOSS / A score =4-point time

Secondary Outcome Measures

Name	Time	Method
recoving time	1day	Wake up time
Drug dosage	1day	dosage of dexmeditomidine and remimazolam

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China