UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009869 |
|---|---|
| Receipt number | 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 10:51:55 |
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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
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
si-soumu-syomu@office.osaka-u.ac.j
Sponsor or person
Institute
Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011562
