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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Adolescent idiopathic scolioses

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

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

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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