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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033129
Receipt No. R000037780
Scientific Title The effects of hydroxyzine on the emergence delirium in pediatric patients after hypospadias repair surgery
Date of disclosure of the study information 2018/08/01
Last modified on 2018/06/24

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Basic information
Public title The effects of hydroxyzine on the emergence delirium in pediatric patients after hypospadias repair surgery
Acronym The effect of hydroxyzine on the emergence delirium
Scientific Title The effects of hydroxyzine on the emergence delirium in pediatric patients after hypospadias repair surgery
Scientific Title:Acronym The effect of hydroxyzine on the emergence delirium
Region
Japan

Condition
Condition hydorpadias
Classification by specialty
Urology Anesthesiology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we investigate if intraoperative administration of hydroxyzine reduces the incidence of emergence delirium in young children after hypospadias surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Watcha scale
Key secondary outcomes behaviors led to accidental catheter removal, restraint, and use of sedatives to calm down patients.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 hydroxyzine 1mg/kg is administered intravenously at the end of surgery.
Interventions/Control_2 saline is administered intravenously at the end of surgery.
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
1 years-old <=
Age-upper limit
3 years-old >=
Gender Male
Key inclusion criteria young children who undergo hypospadias repair surgery
Key exclusion criteria ASA physical status>2
patients with arrhythmia
patients who take anticonvulsants
mental retardation
patients with previous history of emergence delirium
allergy to hydroxydine
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Igarashi Ayuko
Organization Miyagi Prefectural Hospital
Division name Department of Anesthesia
Zip code
Address 4-3-17 Ochiai, Aoba-ku, Sendai, Miyagi
TEL 022-391-5111
Email igarashi-ayu@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayuko Igarashi
Organization Miyagi Prefectural Hospital
Division name Department of Anesthesia
Zip code
Address 4-3-17 Ochiai, Aoba-ku, Sendai, Miyagi
TEL 022-391-5111
Homepage URL
Email igarashi-ayu@umin.ac.jp

Sponsor
Institute Department of Anesthesia, Miyagi Prefectural Hospital
Institute
Department

Funding Source
Organization no funding
Organization
Division
Category of Funding Organization Other
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
2018 Year 08 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 08 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
2018 Year 06 Month 24 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037780

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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