NCT06755996

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 7, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 25, 2024

Last Update Submit

January 25, 2026

Conditions

Fiberoptic Bronchoscopy

Outcome Measures

Primary Outcomes (1)

  • Sedation success rate

    MOSS / A score =4-point time

    1day

Secondary Outcomes (2)

  • recoving time

    1day

  • Drug dosage

    1day

Study Arms (2)

DR1 group

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine injectionDrug: Remimazolam

DR2 group

EXPERIMENTAL

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

Drug: Remimazolam

Interventions

Dexmedetomidine injectionDRUG

Dexmedetomidine injection 3μg/kg

Also known as: dex inj
DR1 group
RemimazolamDRUG

remimazolam 0.5mg / kg

Also known as: remi
DR1 groupDR2 group

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-6 years old (24\~72 months);
  • ASA I-II;
  • sign the informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Interventions

Dexmedetomidineremimazolam

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • pu zhou, Dr.

    Tongji Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 25, 2024

First Posted

January 1, 2025

Study Start

January 7, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)