Fiberoptic BronchoscopyNCT06755996
Dexmedetomidine Nasal Spray and Pediatric Bronchoscopy
A study testing Dexmedetomidine injection and Remimazolam in people with Fiberoptic Bronchoscopy, run by Tongji Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Fiberoptic Bronchoscopy
- What is being tested?
- Dexmedetomidine injection and Remimazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-6 years old (24~72 months);
- ASA I-II;
- sign the informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Fiberoptic Bronchoscopy
- Being tested
- Dexmedetomidine injection, Remimazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Also called dex inj
Dexmedetomidine injection 3μg/kg
RemimazolamDrug
Also called remi
remimazolam 0.5mg / kg
| Study group | Role | What they receive |
|---|---|---|
| DR1 group | Active comparator | Dexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group Receives: Drug: Dexmedetomidine injection; Drug: Remimazolam |
| DR2 group | Experimental | Dexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group Receives: Drug: Remimazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation success rate
MOSS / A score =4-point time
Measured: 1day
Secondary outcomes (2)
recoving time
Wake up time
Measured: 1day
Drug dosage
dosage of dexmeditomidine and remimazolam
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start7 Jan 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fiberoptic BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- pu zhou, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755996
- Sponsor's protocol ID
- DEXS
- Status last verified
- Jan 2026
- First submitted
- 25 Dec 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Dexmedetomidine Nasal Spray and Remimazolam for the Treatment of Pediatric Bronchoscopy
- ClinicalTrials.gov ID
- NCT06755996
- Acronym / sponsor ID
- DEXS
- Conditions
- Fiberoptic Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR1 group | Active comparator | Drug: Dexmedetomidine injection, Drug: RemimazolamDexmedetomidine injection 3μg/kg+ remimazolam 0.5mg/kg group |
| DR2 group | Experimental | Drug: RemimazolamDexmedetomidine nasal spray 3μg/kg+ remimazolam 0.5mg/kg group |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 2-6 years old (24~72 months);
- ASA I-II;
- sign the informed consent.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine injectionAlso: dex injDexmedetomidine injection 3μg/kg | Drug | DR1 group |
| RemimazolamAlso: remiremimazolam 0.5mg / kg | Drug | DR1 group, DR2 group |
Primary outcome
Sedation success rate
Time frame: 1day
MOSS / A score =4-point time
2 secondary outcomes
recoving time
Time frame: 1day
Drug dosage
Time frame: 1day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Fiberoptic Bronchoscopy
Not yet recruiting
Sensory Isolation to Reduce Anxiety During Bronchoscopy
Anxiety Physiological Stress Responses ,Fiberoptic Bronchoscopy, Sensory Isolation
Active, not recruiting
the Value of Flexible Bronchoscopy in the Neonatal Intensive Care Unit at Sohag University Hospitals
Study Including Neonates Who Underwent Flexible Fiberoptic Bronchoscopy in Last 10 Years at Sohag University Hospitals
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
pu zhou, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine injection and Remimazolam in people with Fiberoptic Bronchoscopy, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedation success rate (time frame: 1day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.