- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02077712
Intranasal Dexmedetomidine Sedation for Ophthalmic Examinations in Children (DEX-EYE)
April 29, 2016 updated by: Haotian Lin, Sun Yat-sen University
A Randomised Comparison of Two Intranasal Dexmedetomidine Doses for Ophthalmic Examination Following Failed Chloral Hydrate Sedation in Children
2 ug/kg of intranasal dexmedetomidine could produce satisfactory sedation in more children for ophthalmic examinations than the sedative effect of 1ug/kg.
Study Overview
Detailed Description
Dexmedetomidine is an a2-adrenergic receptor agonist that provides sedation without respiratory depression.Clinical trials have demonstrated that intranasal dexmedetomidine in a dose of 1ug/kg produces satisfactory sedation in between 53% and 57% of children at anaesthetic induction.
There are also reports using higher doses of intranasal dexmedetomidine.
The investigators compared the sedative effect of 1ug/kg intranasal dexmedetomidine with those of 2 ug/kg for ophthalmic examinations in children aged 2 months-10 years and hypothesised that the higher dose would produce satisfactory sedation in more children at the time of anaesthetic induction.
Study Type
Interventional
Enrollment (Anticipated)
60
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 Contact
- Name: Haotian Lin
- Phone Number: 862087330493
- Email: gddlht@aliyun.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Zhongshan Ophthalmic Center
-
Contact:
- Haotian Lin
- Phone Number: 862087330493
- Email: gddlht@aliyun.com
-
-
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
2 months to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Need sedation for ophthalmic examinations
- Children who had failed chloral hydrate sedation, i.e.there was no evidence of sedation 30 min following administration.
- With informed consent from parents
Exclusion Criteria:
- Children with gastroesophageal reflux
- Children with nausea and vomiting
- Children with apnea in the past three months
- Children with recent pneumonia, exacerbation of asthma, bronchitis and upper respiratory tract infection
- Children with severe arrhythmias, heart failure and cardiac structural abnormalities
- Children with facial abnormalities, who is expected to be difficult with effective mask ventilation
- Children with severe neurological disease
- Children with moyamoya disease
- Children who is allergy to For dexmedetomidine or chloral hydrate
- Preterm children, weight <2 kg
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dexmedetomidine 1 ug/kg
1 ug/kg of intranasal dexmedetomidine
|
1 or 2 ug/kg of intranasal dexmedetomidine
Other Names:
|
Active Comparator: Dexmedetomidine 2 ug/kg
2 ug/kg of intranasal dexmedetomidine
|
1 or 2 ug/kg of intranasal dexmedetomidine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Numbers of participants with successful rescue sedation
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Numbers of participants with completement of ophthalmic examinations
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Yizhi Liu, Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
- Principal Investigator: Xiaoliang Gan, Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study Director: Weirong Chen, Zhongshan Ophthalmic Center, Sun Yat-sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ambi US, Joshi C, Ganeshnavar A, Adarsh E. Intranasal dexmedetomidine for paediatric sedation for diagnostic magnetic resonance imaging studies. Indian J Anaesth. 2012 Nov;56(6):587-8. doi: 10.4103/0019-5049.104588. No abstract available.
- Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
- Ray T, Tobias JD. Dexmedetomidine for sedation during electroencephalographic analysis in children with autism, pervasive developmental disorders, and seizure disorders. J Clin Anesth. 2008 Aug;20(5):364-368. doi: 10.1016/j.jclinane.2008.03.004.
- Li BL, Yuen VM, Song XR, Ye J, Ni J, Huang JX, Irwin MG. Intranasal dexmedetomidine following failed chloral hydrate sedation in children. Anaesthesia. 2014 Mar;69(3):240-4. doi: 10.1111/anae.12533. Epub 2014 Jan 21.
- Gan X, Lin H, Chen J, Lin Z, Lin Y, Chen W. Rescue Sedation With Intranasal Dexmedetomidine for Pediatric Ophthalmic Examination After Chloral Hydrate Failure: A Randomized, Controlled Trial. Clin Ther. 2016 Jun;38(6):1522-1529. doi: 10.1016/j.clinthera.2016.04.036. Epub 2016 May 24.
Helpful Links
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
February 1, 2014
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
February 27, 2014
First Submitted That Met QC Criteria
March 2, 2014
First Posted (Estimate)
March 4, 2014
Study Record Updates
Last Update Posted (Estimate)
May 3, 2016
Last Update Submitted That Met QC Criteria
April 29, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Hypnotics and Sedatives
- Dexmedetomidine
Other Study ID Numbers
- CCPMOH2010-China4
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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