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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009869
Receipt No. R000011562
Scientific Title Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty
Date of disclosure of the study information 2013/01/25
Last modified on 2013/01/25

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Basic information
Public title Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty
Acronym Usefulness of dexmedetomidine
Scientific Title Usefulness of dexmedetomidine for prevention of emergent agitation in infants undergoing palatoplasty
Scientific Title:Acronym Usefulness of dexmedetomidine
Region
Japan

Condition
Condition cleft palate
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The incidence of emergent agitation (EA) after sevoflurane (Sev) anesthesia is high in infants. Although opioids are often used for pain control and to reduce the incidence and severity of EA, anesthesiologists must pay attention to the risk of postoperative resiratory complications. This is particularly important in infants undergoing palatoplasty because edema at the operative site leads to obstructive symptoms and hypoxemia. Dexmedetomidine (Dex) has sedative and analgesic properties without respiratory depression. Some studies have shown the effectiveness of Dex in postoperative recovery, however, the usefulness of Dex in infants undergoing palatoplasty has not yet been well established. We designed a prospective, double-blind, randomized control study to determine the effects of Dex on postoperative recovery in infants undergoing palatoplasty.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine the effects of Dex on postoperative recovery in infants undergoing palatoplasty.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 In the Dex group, Dex was given from about 10 minutes before the end of the operation.
Interventions/Control_2 In the saline group, the equivalent amount of saline was administered in the same manner.
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
10 months-old <=
Age-upper limit
14 months-old >=
Gender Male and Female
Key inclusion criteria Participants were required to be ASA physical status class1, aged 10 to 14 months years old, weight between 7 and 10 kg, and have a height between 70 and 80 cm.
Key exclusion criteria Exclusion criteria included patient refusal, ASA class2, cardiovascular disease, or allergy.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Boku Aiji
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address 1-8, Yamadaoka, Suita, Japan
TEL 06-6879-2972
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesiology
Zip code
Address
TEL
Homepage URL
Email si-soumu-syomu@office.osaka-u.ac.j

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Osaka University Graduate School of Dentistry
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
2013 Year 01 Month 25 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
2011 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2011 Year 09 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
2013 Year 01 Month 25 Day
Last modified on
2013 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011562

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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