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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016847
Receipt No. R000019553
Scientific Title Prevention of post operative nausea and vomiting with dexamethasone in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scolioses : A randomized double-blind clinical trial
Date of disclosure of the study information 2015/05/01
Last modified on 2019/02/14

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Basic information
Public title Prevention of post operative nausea and vomiting with dexamethasone in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scolioses : A randomized double-blind clinical trial
Acronym Prevention of post operative nausea and vomiting with dexamethasone in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scolioses : A randomized double-blind clinical trial
Scientific Title Prevention of post operative nausea and vomiting with dexamethasone in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scolioses : A randomized double-blind clinical trial
Scientific Title:Acronym Prevention of post operative nausea and vomiting with dexamethasone in children and adolescents undergoing posterior spinal fusion for adolescent idiopathic scolioses : A randomized double-blind clinical trial
Region
Japan

Condition
Condition Adolescent idiopathic scolioses
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether dexamethasone prevents PONV in children and adolescents undergoing posterior spinal
fusion for adolescent idiopathic scolioses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of PONV within 72h after 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 Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Dexamethasone (0.15 mg/kg) at the induction of anesthesia (n=50)
Interventions/Control_2 Saline at the induction of anesthesia (n=50)
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 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing posterior spinal fusion for adolescent idiopathic scoliosis with ASA PS I or II
Key exclusion criteria Contraindication to the use of any of the study medications.
Patients who took steroids or immunosuppressant within 1 month prior to the surgery.
Patients who took antiemetics within 24h prior to the surgery.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Morisaki
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo
TEL 03-3353-1211(61608)
Email morisaki@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Rie Wakamiya
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL 070-6587-1141
Homepage URL
Email eriya@keio.jp

Sponsor
Institute Department of Anesthesiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Anesthesiology, Keio University School of Medicine
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
2015 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.nature.com/articles/s41598-019-38764-8
Number of participants that the trial has enrolled
Results
The 72 h incidence of PONV was significantly lower in the dexamethasone group than in the control group (62.5% vs 84.0%; RR 0.74, 95% CI 0.58-0.96, P=0.02). During the first and second 24 h postoperative intervals, fewer patients in the dexamethasone group received rescue antiemetics. Visual analogue scale scores for nausea and pain were lower in the dexamethasone group than in the control group during the first 24 h postoperatively. Dexamethasone did not increase the number of adverse events. The results of this study showed that a single dose of dexamethasone was effective for reducing PONV after paediatric scoliosis correction surgery.
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 Main results already published
Date of protocol fixation
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2018 Year 11 Month 01 Day
Date of closure to data entry
2018 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 19 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019553

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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