Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy

January 25, 2026 updated by: aijun xu, Tongji Hospital

Combination of Dexmedetomidine Nasal Spray and Remimazolam for the Treatment of Pediatric Bronchoscopy

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 Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DR1 group
Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group
Drug: Dexmedetomidine injection
Dexmedetomidine injection 3μg/kg
Other Names:
  • dex inj
Drug: Remimazolam
remimazolam 0.5mg / kg
Other Names:
  • remi
Experimental: DR2 group
Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group
Drug: Remimazolam
remimazolam 0.5mg / kg
Other Names:
  • remi

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Chair: pu zhou, Dr., Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

December 25, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEXS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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