UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020446 |
|---|---|
| Receipt number | R000023623 |
| Scientific Title | Intranasal Premedication with Dexmedetomidine and midazolam in ophthalmic surgery for pediatrics, are they really equally effective? |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/01/05 20:43:09 |
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Basic information
Public title
Intranasal Premedication with Dexmedetomidine and midazolam in ophthalmic surgery for pediatrics, are they really equally effective?
Acronym
Intranasal Premedication with Dexmedetomidine and midazolam in ophthalmic surgery for pediatrics, are they really equally effective?
Scientific Title
Intranasal Premedication with Dexmedetomidine and midazolam in ophthalmic surgery for pediatrics, are they really equally effective?
Scientific Title:Acronym
Intranasal Premedication with Dexmedetomidine and midazolam in ophthalmic surgery for pediatrics, are they really equally effective?
Region
| Africa |
Condition
Condition
now we are writing the discussion and conclusion of the study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of both dexmedetomedine and midazolam given by intranasal rout
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prove that intranasal dexmedetomedine is superior to midazolam as sedative preanesthetic drug in pediatric surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
patient received 0.5 mg/kg midazolam intranasally half hour before anesthesia starting and asses the degree of sedation and separation from parents
Interventions/Control_2
patient received intranasal dexmedetomidine 1 micrograme/kg dexmedetomidine .
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who were submitted for elective ophthalmic surgery.
2. ASA 1,2
3. Age: 2-6 years
Key exclusion criteria
1. Parent refusal.
2. Patients suffering from congenital cardiac disease.
3. History of allergy to any of the studied drugs.
4. Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ghada Fouad Mohamed |
Organization
Mansoura university ophthalmology center, mansoura faculty of medicine, mansoura university
Division name
anethesia and intensive care department
Zip code
Address
12 saad zaghloul street, mansoura dakahlya egypt
TEL
+81-1008081333
ghadafouad2013@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ghada Fouad Mohamed |
Organization
Mansoura university ophthalmology center, mansoura faculty of medicine, mansoura university
Division name
anethesia and intensive care department
Zip code
Address
12 saad zaghloul street, mansoura dakahlya egypt
TEL
+81-1008081333
Homepage URL
ghadafouad2013@hotmail.com
Sponsor or person
Institute
mansoura faculty of medicine, mansoura university
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
