UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016847
Receipt number 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 08:21:07

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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 or person

Institute

Department of Anesthesiology, Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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