Using dexmedetomidine nasal spray for sedation in children undergoing bronchoscopy
Combination of Dexmedetomidine Nasal Spray and Remifentanil for the Treatment of Pediatric Bronchoscopy
This study is testing if a nasal spray with dexmedetomidine can help calm young children during bronchoscopy procedures when used with another medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06755996 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the sedative effects of dexmedetomidine nasal spray when used in combination with remimazolam for pediatric bronchoscopy procedures. The approach involves administering dexmedetomidine via nasal spray, which is designed to provide a simple and effective means of achieving sedation and reducing anxiety in young patients. The study will observe the efficacy and safety of this method in children aged 2 to 6 years, focusing on creating a more comfortable anesthesia experience during bronchoscopy. The goal is to enhance the overall safety and comfort of the procedure for pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 6 years who are classified as ASA I-II.
Not a fit: Patients with severe nasal conditions, liver or kidney dysfunction, or significant nutritional deficiencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more comfortable bronchoscopy procedures for children.
How similar studies have performed: While the use of dexmedetomidine in various forms has been explored, the specific application of a nasal spray for pediatric bronchoscopy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Tongji hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Aijun Xu, Dr.
- Email: ajxu@tjh.tjmu.edu.cn
- Phone: 18627784217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.