UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief 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
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	Hiroshi Morisaki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211(61608)
Email	morisaki@z8.keio.jp

Public contact
Name of contact person	Rie Wakamiya
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.nature.com/articles/s41598-019-38764-8
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.
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