Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

NCT ID: NCT06755996

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-07

Study Completion Date

2025-08-31

Brief Summary

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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

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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

Conditions

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Fiberoptic Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DR1 group

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine injection

Intervention Type DRUG

Dexmedetomidine injection 3μg/kg

Remimazolam

Intervention Type DRUG

remimazolam 0.5mg / kg

DR2 group

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

remimazolam 0.5mg / kg

Interventions

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Dexmedetomidine injection

Dexmedetomidine injection 3μg/kg

Intervention Type DRUG

Remimazolam

remimazolam 0.5mg / kg

Intervention Type DRUG

Other Intervention Names

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dex inj remi

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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aijun xu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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pu zhou, Dr.

Role: STUDY_CHAIR

Tongji Hospital

Locations

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Tongji hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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DEXS

Identifier Type: -

Identifier Source: org_study_id

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