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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020446
Receipt No. 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

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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
Email 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
Email ghadafouad2013@hotmail.com

Sponsor
Institute mansoura faculty of medicine, mansoura university
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023623

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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