Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy | NCT06755996

Studies
Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

NCT06755996

Sponsor

Tongji Hospital

Status

Completed

Last Update Posted

Jan 27, 2026Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Fiberoptic Bronchoscopy

Interventions

Dexmedetomidine injection
Remimazolam

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2025Actual

Primary Completion Date

Aug 31, 2025Actual

Completion Date

Aug 31, 2025Actual

First Submitted Date

Dec 25, 2024

First Submission Date that Met QC Criteria

Dec 25, 2024

First Posted Date

Jan 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2026

Last Update Posted Date

Jan 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DR1 group	Active Comparator	Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group	Drug: Dexmedetomidine injection Drug: Remimazolam
DR2 group	Experimental	Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group	Drug: Remimazolam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine injection	Drug	Dexmedetomidine injection 3μg/kg	DR1 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sedation success rate	MOSS / A score =4-point time	1day

Secondary Outcomes

Measure	Description	Time Frame
recoving time	Wake up time	1day
Drug dosage	dosage of dexmeditomidine and remimazolam	1day

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
pu zhou, Dr.	Tongji Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji hospital		Wuhan	Hubei	430030	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020927	Dexmedetomidine
C522201	remimazolam

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

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Browse Branches

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